Neoplasms

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Head and Neck Neoplasms

Lymphedema

Fibrosis

Lymphatic Diseases

Participants will be evaluated for LEF status using the HN-LEF Grading Criteria and neck range of motion using the Cervical Range of Motion Device. Participants also complete study questionnaires, including VHNSS and LSIDS-H\&N. Participants undergo ultrasound shear wave elastography over 20-25 minutes. Participants' cancer disease and treatment information will be gathered from their medical records.

Evaluation of secondary lymphedema and fibrosis (LEF) status

Medical Examination

Questionnaire Administration

Undergo ultrasound shear wave elastrography

Shear Wave Elastography

Kenneth Niermann

This research trial studies skin/soft tissue elasticity in head and neck cancer survivors with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck cancer which may lead to skin tightness, pain, and body image issues. Early detection of lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave elastography is a technique that provides a quantitative measure of stiffness using a push pulse to generate shear waves within the tissues. Conventional imaging techniques are then used to monitor the shear waves generated through the tissue to calculate the shear wave speed. Shear wave elastography may help obtain an early and accurate measurement of tissue elasticity in head and neck cancer survivors.

PRIMARY OBJECTIVES:

I. To obtain pilot data of the elasticity of skin/soft tissues using shear wave elasticity at the defined anatomical sites in head and neck cancer survivors with lymphedema and fibrosis (LEF).

II. To explore the correlation between elasticity of skin/soft tissues and the following: 1) symptoms as measured by the Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN); 2) functional impact as measured by Cervical Range of Motion Device and the Vanderbilt Head and Neck Symptom Survey; and 3) physical exam findings as measured by Head and Neck LEF Grading Criteria.

OUTLINE:

Participants will be evaluated for LEF status using the Head and Neck External Lymphedema - Fibrosis (HN-LEF) Grading Criteria and neck range of motion using the Cervical Range of Motion Device. Participants also complete study questionnaires, including Vanderbilt Head and Neck Symptom Survey (VHNSS) and Lymphedema Symptom Intensity and Distress Survey - Head and Neck (LSIDS-H\&N). Participants undergo ultrasound shear wave elastography over 20-25 minutes. Participants' cancer disease and treatment information will be gathered from their medical records.

Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis

Assessing Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors

Descriptive statistics will be used to describe data from elasticity measure. Of particular interest will be the measures of central tendency and variability at the multiple sites. Sites with higher variability (coefficient of variation) that others may be indicative of less reliable assessment.

Correlation coefficients will be used to assess the strength of the associations of the elasticity values with the respective LEF grades (HN-LEF) for the respective sites. Those values will also be correlated with Vanderbilt Head and Neck Symptom Survey and HN-LSIDS symptom and Cervical Range of Motion scores. Due to the large number of correlations proposed in this study, effect sizes (strength of the associations) and clinically significant patterns will be of much greater importance than statistical significance.

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Principal Investigator

Digestive System Diseases

Rare Diseases

Carcinoma

Cholangiocarcinoma

Neoplasm Metastasis

Carcinoma, Hepatocellular

Liver Neoplasms

Hyperplasia

Hemangioma

Focal Nodular Hyperplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neoplasms, Vascular Tissue

Bile Duct Cancer

Nodular Regenerative Hyperplasia

Hematinics

All Drugs and Chemicals

Liver Extracts

Measurement of tumor stiffness by Shear wave elastography - SWE™

Shear wave elastography

Ivica Grgurevic, MD, PhD

Shear Wave Elastography (SWE™) is a quantitative elastography method for measuring tissue stiffness. The difference in stiffness between benign and malignant tumors has been demonstrated by other elastography methods (acoustic radiation force impulse imaging, transient elastography and/or magnetic resonance elastography). The investigators hypothesized that benign liver tumors are softer than malignant liver tumors measured by SWE™, allowing differentiation between the two by tumor stiffness expressed in kilopascal (kPa). In this study benign and malignant liver tumors will be evaluated in five groups: 1) hemangioma and 2) focal nodular hyperplasia (FNH) representing the most common benign liver tumors; 3) metastases and 4) cholangiocarcinoma (CCC), both presenting malignant tumors mostly appearing in otherwise healthy liver, and 5) hepatocellular carcinoma (HCC) mostly occurring in cirrhotic liver, which can potentially influence elastographic measurements therefore querying the appropriateness of comparison between tumors in healthy and cirrhotic liver. Enrolled patients will undergo transabdominal ultrasonography and SWE™ examination. The tumor stiffness will be measured five times for each tumor. Additionally, surrounding liver parenchyma stiffness will be measured. The nature of the liver tumor will be defined through a standard diagnostic workup according to current guidelines, including contrast enhanced multi-slice CT, MRI and/or cytology/histology, as applicable. In the final analysis the mean tumor stiffness and tumor-parenchyma ratio will be calculated for each group as well as for benign and malignant tumors separately, and cut-off values for the differentiation of various groups will be derived. The clinical value of the method will be appraised based on specificity, sensitivity, positive and negative predictive values, and AUC.

Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors

Quantitative Real-time Ultrasound Elastography (Shear Wave Elastography - SWE™) for Characterisation of Liver Tumors

tumor stiffness expressed in kPa, measured by ShearWave ™ Elastography (SWE™) Aixplorer® ultrasound machine from SuperSonic Imagine, Aix-en-Provence, France

comparison between tumor and surrounding liver parenchyma stiffness as expressed by tumor to liver parenchyma stiffness ratio

University Hospital Dubrava

associate professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.

Undergo ultrasound-based elastography imaging using the Aixplorer system

Ultrasound Elasticity Imaging

Undergo standard of care ultrasound-guided prostate biopsy

Ultrasound-Guided Prostate Biopsy

Ethan Halpern, MD

This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.

PRIMARY OBJECTIVES:

I. To evaluate the detection of prostate cancer with elastography using the Aixplorer scanner.

SECONDARY OBJECTIVES:

I. To obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy.

II. To compare the Gleason grade of prostate cancers detected with elastography to the Gleason grade of tumors detected by conventional systematic biopsy.

Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy

Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate

Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk.

Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient).

Sidney Kimmel Cancer Center at Thomas Jefferson University

Gland and Hormone Related Diseases

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Non Invasive Imaging Technique. CEUS involves the use of microbubble contrast agents and specialized imaging techniques to enhance the signal from blood, thus showing flow in macroscopic vessels as well as tissue perfusion informatio

Contrast-enhanced ultrasound

Non Ivasive Imaging Technique. Shear Wave Elastography (SWE) is a recently developed technique that uses ultrasound to noninvasively assess the mechanical stiffness of tissue by measuring tissue distortion in ponse to an acoustic radiation force impulse from a focused ultrasound beam.

UltraSound System Cleared by FDA 510 (k) K180067

Sequoia System

Edward Grant, MD

Our overall hypothesis is that Contrast-enhanced ultrasound (CEUS) and Shear Wave Elastography (SWE) will allow for high diagnostic accuracy of benign and malignant thyroid nodules, which will correlate with and complement the ACR TI-RADS classification system, allowing for more accurate diagnosis of benign and malignant thyroid nodules.

Thyroid nodules are an exceedingly common clinical entity, however, only a small percentage of nodules are malignant. Conventional ultrasound is the current standard for the initial evaluation of thyroid nodules, yet due to several overlapping characteristics between benign and malignant nodules its utility in diagnosis has been limited, leading to a high rate of negative biopsies. To overcome these challenges the American College of Radiology has proposed a Thyroid Imaging Reporting and Data System (TI-RADS) in an effort to decrease unnecessary biopsies \[5\]. While these efforts have shown encouraging results, further work is still needed. Contrast-enhanced ultrasound (CEUS) and Shear Wave Elastography (SWE) are two emerging non-invasive imaging techniques which have shown promising results in the evaluation of thyroid nodules. However, data is limited and how these imaging modalities could potentially compliment ACR TI-RADS is unknown.

Eligible subjects who consent for this study will undergo a SWE and CEUS evaluation of their thyroid gland at the time of their standard of care scheduled thyroid biopsy

Utility of Contrast-Enhanced Sonography and Shear Wave Elastography

Utility of Contrast-Enhanced Sonography and Shear Wave Elastography in Conjunction With ACR TI-RADS for the Evaluation of Thyroid Nodules

Kappa analysis will be used to assess the agreement between the two radiologists visual assessment result. The rating result of each radiologist will be compared to the pathological result using Kappa analysis as well.

Kappa analysis will be used to re-assess the agreement between the two radiologists visual assessment result. Any disagreement between the radiologists will need to be reconciled and consensus reached. The final assessment result from the radiologists will be compared to the cytology and/or surgical gold standard using anther Kappa test.

Siemens Medical Solutions USA - CSG

University of Southern California

Professor

Rectal Neoplasms

Adenoma

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

SWE value measurement will be added during the ERUS examination.

Søren R Rafaelsen, DMSc

The diagnosis of rectal lesions is a challenging task, and the accuracy of the primary staging is important preoperatively. A relatively novel technology makes it possible to measure the tissue stiffness during endorectal ultrasonography.

The purpose of this study is to evaluate the diagnostic value of Shear Wave Elastography (SWE). The hypothesis is that the tissue stiffness is higher in malignant tissue than in benign lesions.

This study will include patients with an endoscopy verified rectal lesion referred to the radiology department for pretreatment evaluation.

During the investigation, patients will undergo magnetic resonance imaging (MRI) and endorectal ultrasonography (ERUS). During the ERUS, the tissue stiffness of the lesion and visible lymph nodes will be measured using the SWE technology.

Hypotheses:

1. Tumour stiffness measurement by SWE gives a statistically significantly higher value in malignant processes than in benign rectal tumors.
2. Tissue stiffness measurement with SWE gives a statistically significantly higher value in lymph node metastases than in reactive enlarged lymph nodes.
3. There is a statistically significant correlation between SWE and MRI apparent diffusion coefficient (ADC)

Histopathology report of surgical specimen will serve as endpoint.

Shear Wave Elastography of Rectal Adenomas and Cancer

The accuracy of SWE value as compared with the histopathology report

The correlation between ERUS SWE and MRI ADC value

Vejle Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Shear wave elastography (SWE) is an emerging technology that provides information about the inherent elasticity of tissues by producing an acoustic radiofrequency force impulse, sometimes called an "acoustic wind," which generates transversely-oriented shear waves that propagate through the surrounding tissue and provide biomechanical information about tissue quality. Although SWE has the potential to revolutionize bone and joint imaging, its clinical application has been hindered by technical and artifactual challenges. Many of the stumbling blocks encountered during musculoskeletal SWE imaging are readily recognizable and can be overcome, but progressive advances in technology and a better understanding of image acquisition are required before SWE can reliably be used in musculoskeletal imaging.

shear wave elastography

rehab awad mohamed ahmed

The aim of this study is to investigate the role of shear wave elastography (SWE) for early assessment of response to neoadjuvant chemotherapy in patients with invasive breast cancer.

Neoadjuvant chemotherapy (NACT) is often used to treat patients with locally advanced breast cancer, large tumor but operable breast cancer, or proven lymph node metastasis. The advantage of NACT is that it can downstage tumor size and increase the rate of breast-conserving surgery as well as providing information on the drug response through assessment of the changes of tumor size . The pathological complete response has consistently been associated with good long-term outcomes, but is achieved in only 10%-20% of cases. Patients who achieve a pathological complete response have a better prognosis than those who do not . Higher rates of pathological complete response can be achieved when selecting for certain breast cancer subtypes and treatment regimens .

Breast cancer is a heterogeneous disease that can be divided into different subtypes by immunohistochemical marker expression or gene expression array data. A new surrogate intrinsic subtype was proposed at the St Gallen meeting to separate luminal A, luminal B (HER2-/HER2+), HER2-enriched, and triple-negative disease . Similarly, tumors may have different prognosis based on their molecular subtypes. The luminal A subtype has a better prognosis than the other subtypes, and the triple-negative subgroup has the worst prognosis . On the other hand, the triple-negative subtype is more sensitive to chemotherapy than luminal A and B breast cancer .

Current techniques available for monitoring response to NACT are positron emission tomography (PET) , sonography, mammography, magnetic resonance imaging (MRI) , and shear wave elastography (SWE) . Conventional sonography and mammography have poor reliability in evaluating the size of residual tumor after chemotherapy . SWE is a recently developed low-cost imaging technique for measuring tissue stiffness in a noninvasive and quantitative manner with high reproducibility . Tissue stiffness has been demonstrated to be significantly correlated with tumor growth as cancer development and progression require extensive reorganization of the extracellular matrix (ECM) . Increased deposition of collagen and other ECM molecules enhances the stiffness of tumoral stroma . Changes in tumor stiffness were significantly greater in patients who had a good response to NACT compared to those resistant to NACT. Breast cancer pre- and post-treatment stiffness obtained from SWE was significantly correlated with the presence of residual cancer . A study in showed that the SWE stiffness measured after 3 cycles of NACT and changes in stiffness from baseline were strongly associated with pCR after 6 cycles. The combination of the post-treatment SWE and grey scale ultrasound has also been shown to be promising for end-of-treatment identification of residual disease and thus response to NACT, with similar accuracies found in assessment by MRI .

Several histopathological classifications are available to categorize the tumor response to NACT. The Miller-Payne grading (MPG) and Residual Disease in Breast and Nodes (RDBN) are systems to assess the pathological response of NACT. MPG provides a five-step scale based on tumor cellularity in the excision/mastectomy specimen compared with the pretreatment core biopsy as follows: grade 1, no reduction in overall cellularity; grade 2, minor (\<30%) loss of cellularity; grade 3, estimated 30%-90% reduction in tumor cells; grade 4, \>90% loss of tumor cells; and grade 5, no invasive carcinoma (IC); ductal carcinoma in situ may be present.\[30\] RDBN uses the following formula: level 1, pathological complete response in breast and nodes, without or with carcinoma in situ, and levels 2-4, residual disease in three different amounts, calculated as 0.2 (residual breast tumor size in cm) + the index for the involved nodes (0 for no positive nodes, 1 for 1-4 nodes, 2 for 5-7 nodes, 3 for ≥8 nodes) + the Scarff-Bloom-Richardson grade (1, 2, or 3), which takes into account tumor size, lymph node stage, and histological grade to determine response.

Shear Wave Elastography Assessment of Neoadjuvant Chemotherapy Response in Patients With Invasive Breast Cancer

Early Assessment of Shear Wave Elastography Parameters to Assess the Response to Neoadjuvant Chemotherapy in Patients With Invasive Breast Cancer

measurement of shear wave elastography parameters in patients with invasive breast cancer before and after neoadjuvant chemotherapy and assess the residual cancer burden for each patient.

Assiut University

principle investigator

Musculoskeletal Diseases

Nervous System Diseases

Wounds and Injuries

Neck Pain

Pain

Shoulder Pain

Dyskinesias

Accessory Nerve Injuries

Arthralgia

Joint Diseases

Neurologic Manifestations

Accessory Nerve Diseases

Cranial Nerve Diseases

Cranial Nerve Injuries

Craniocerebral Trauma

Trauma, Nervous System

Participants in the control group will receive usual care ( standard physical therapy program)

Particiapnts in intervevention group will receive both usual care and myofascial release techniques

Sternocleidomastoid, Upper trapezius, Suboccipital region, Scalenes, Pectoral release, Scapular and hyoid mobilization techniques.

Duration: 6 weeks, 1 supervised session per week, and the session lasted 30 minutes.

Myofascial Release Technique

Therapeutic exercise: passive and active range of motion, strengthening and postural exercise in order to improve shoulder and cervical mobility, muscle flexibility, strength and endurance, postural control and movement patterns; 2) stretching of pectoral muscles and serratus anterior; 3) scar tissue massage to reduce scar tissue's stiffness.

Duration of the intervention: 6 weeks (1 supervised session and 2 individual per week). Each exercise will be done 1-3 sets and 5-10 repetitions.The session lasted 30 minutes.

Exercise diary will be utilized in order to follow the exercise program.

Exercise

Circular, Up and Down, Side to Side technique

Scar Tissue Massage

Ferhat SIMSEK, PhD(c)

Ali F OKYAR, Dr.

Ferhat SIMSEK, MSc

Ali Fethi OKYAR, PhD

As the head and neck cancer (HNC) survival rate has increased and therefore, the focus of post-treatments is to improve the quality of patients' life by decreasing the side effects. Treatment of HNC leads to acute and chronic soft tissue damage, and functional loss. However, patients with HNC need having rehabilitation throughout the post-treatment phase so as to improve functional outcomes because of the long term side effects. Chronic shoulder morbidity is one of the complications after surgery due to spinal accesory nerve injury. Moreover, pain, dysphonia, and musculoskeletal impairments are observed in the individuals after the treatments and the patients also have trouble swallowing problems, loss of taste, dry mouth, trismus, nausea, vomiting, and fatigue during and after therapy. Since there is limited research on the usage of manual therapy techniques in HNC patients, this study aims to investigate muscle changes after surgery and the effectiveness of physiotherapy on muscle material behaviour from a biomechanical perspective by using shear wave elastography. In this respect, the hypothesis is:

H0: Physical therapy interventions do not impact mechanical properties of muscle, pain, quality of life, cervical and shoulder functionality in HNC patients after neck dissection.

H1: Physical therapy interventions will improve mechanical properties of muscle, pain, quality of life, cervical and shoulder functionality in HNC patients after neck dissection.

As the HNC survival rate has increased and therefore, the focus of post-treatments is to improve the quality of patients' life by decreasing the side effects. Treatment of HNC leads to acute and chronic soft tissue damage, and functional loss. However, patients with HNC need having rehabilitation throughout the post-treatment phase so as to improve functional outcomes because of the long term side effects. Chronic shoulder morbidity (70% of patients) is one of the common complications after surgery, whereas 84% of survivors complain of their physical appearance due to the remaining head and neck lymphedema (HNL) after radiotherapy. Moreover, pain, dysphonia, and musculoskeletal impairments are observed in the individuals after the treatments and the patients also have trouble swallowing problems, loss of taste, dry mouth, trismus, nausea, vomiting, and fatigue during and after therapy.

Materials might behave in different stress-strain relationships, and it is represented by a stress-strain curve, a basic descriptor of material.Thanks to the stress-strain diagram, differences between materials can be determined such as stiffness, hardness and toughness. Several concepts describe material properties in addition to a stress-strain diagram. For instance, a homogeneous material is one whose properties are not affected by location within the material, anisotropic material is one whose properties are free of direction, and incompressible material retains its volume during deformation. However, the behaviour of soft tissue is anisotropic due to its fibre contents, its constitutive behaviour is nonlinear and incompressible, and it is heterogeneous material owing to its composition, but it can be homogenized under macroscopic analysis. Due to the complexity of soft tissue, its mechanical behaviour is highly affected by density, collagen and elastin's structural arrangement, topographical site, function, and hydrated matrix of proteoglycans. In other words, mechanical properties of soft tissues are related to shape, genetics, age , physical and chemical environmental conditions like strain rate, osmotic pressure and Ph, temperature, which affects skeletal muscle's contractile properties.

It is known that deformable-body changes shape when it is exposed to an external force. In general, several constitutive relations govern the stress and strain relations, for example, plasticity, viscoelasticity, linear elastic, hyperelasticity so on. It is common to use hyperelastic models (i.e. time-independent) so as to determine the association of the stress-strain of soft tissue, even though the biological soft tissues mechanical behaviour is time-dependent . These models are based on the strain energy density which is the energy stored by a system undergoing deformation.

Disuse and immobilization influence muscle fibres harmfully including decreased muscle strength and neural activation of muscle fibre, muscle atrophy, loss of force production and endurance due to decrease in cross-sectional area (CSA). Jones et al., found that immobilization leads to muscle atrophy by decreasing protein synthesis and increasing protein impairment and loss of muscle mass after two weeks of immobilization. Muscle atrophy can exist in the following injury, during an illness such as cancer, sepsis and long term hospitalization. Shortening of myosin and actin filaments alters mechanical properties of muscle because of length-dependent force production. Moreover, the energy production of skeletal muscles is affected during the disuse period by decreasing fat oxidation and enhancing glycolysis, which is a source of muscle energy. Furthermore, muscle composition is impacted due to disuse and inactivity, mainly in type 1 fibre, which maintains postural control. Since radiotherapy and surgery impact negatively on muscle. For instance, after neck dissection, trapezius muscle atrophy seems to be due to SAN injury. It is found that atrophied trapezius muscle's stiffness was significantly lower because of physiological and intrinsic alterations associated with fatty infiltration and atrophy of muscle It is known that physical training affects muscle architecture, such as fibre type distribution, fascicle length, pennation angle and CSA, and force production. Since physical activity contributes to improving the CSA of skeletal muscle, muscle strength and bulk are increased. Moreover, exercise contributes to increased neural activity, contractile tissue and differentiating fibre type. Muscle mechanical properties may change.

Myofascial techniques are one of the manual therapy interventions which focus on treating fascia. It comprises various techniques and interventions such as acupuncture, dry needling, wet needling with pharmaceuticals, and traditional technical approaches such as strain-counter strain, muscle energy technique, positional release, ischemic compression and myofascial release (MFRT). The effectiveness of MFRT has been shown in various trials in different fields. For instance, MFRTs improve outcomes in individuals having shoulder pain, ankle joint restriction, fibromyalgia and lateral epicondylitis. On the other hand, in the cancer field, since MFRTs perform in addition to a standard rehabilitation program, the effect mechanism of MFRT is unclear in cancer . However, it impacts positively on pain, emotions and cancer-related fatigue.

As stated in the surgery part, inflammatory response leads to fibrosis due to increasing edema and healing proteins. This chronic tension that results in abuse, disuse, overuse and anxiety could cause fascial thickening. Within this regard, fascial work is one of the most important parts for treating fibrosis.

As mentioned before, patients with head and neck cancer suffer from the side effects of the treatment. One of the harmful effects of the treatments mostly causes neck and shoulder muscle atrophy, fibrosis and reduction in functionality level. Therefore, it is important to determine changes in mechanical properties of muscles so as to understand effectiveness of physical therapy interventions in HNC patients. To our knowledge, this study will be the first study to directly investigate how neck and shoulder muscles adapt to physical therapy interventions in the scope of material behaviour in HNC patients after neck dissection.

This study will be conducted in Yeditepe University Research Hospital/ Ear Nose and Throat Department.

A randomized single blind controlled clinical trial

Investigation of Effects of Physiotherapy Interventions on Mechanical Properties of Muscle in Head and Neck Cancer

Investigation of Effects of Physioherapy Interventions on Mechanical Properties of Muscle in Head and Neck Cancer

There is not a plan to make IPD available.

It will be measured by Shear Wave Elastography in relax and contracted state of muscle Muscles: M. Upper Trapezius, M. Sternocleidomastoid, M. Masseter /Bilateral

It will be measured by Shear Wave Elastography Muscles: M. Upper Trapezius, M. Sternocleidomastoid, M. Masseter /Bilateral

The Functional Assessment of Chronic Illness Therapy system of Quality of Life- Head and Neck (FACT H\&N Turkish Version)

Active range of motion will be measured by goniometer for both side

Gap between two incisor teeth with full opened mouth

Yeditepe University Hospital

Yeditepe University

PT, MSc

Liver Failure

Hepatic Insufficiency

Patients who underwent curative liver resection for HCC in the First Affiliated Hospital of Sun Yat-Sen University in China.

The radiologist and clinicians will be provided the model prediction results with the explanation of the model and they will fill in a questionnaire to evaluate the usability of the interpretable framework.

The explanation of deep learning framework (VAE-MLP) , including counterfactual explanations and layerwise relevance propagation

The radiologist and clinicians will be provided the model prediction results without the explanation of the model and they will be asked to give their own prediction.

The model prediction

The radiologist and clinicians will be provided the model prediction results with the explanation of the model and they will be asked to give their own prediction.

The model prediction and the explanation of deep learning framework (VAE-MLP) , including counterfactual explanations and layerwise relevance propagation

Xian Zhong

Philippe Lambin

The goal of this in-silico clinical trial is to learn about the usability and clinical effectiveness of an interpretable deep learning framework (VAE-MLP) using counterfactual explanations and layerwise relevance propagation for prediction of post-hepatectomy liver failure (PHLF) in patients with hepatocellular carcinoma (HCC). The main questions it aims to answer are:

* To investigate the usability of the VAE-MLP framework for explanation of the deep learning model.
* To investigate the clinical effectiveness of VAE-MLP framework for prediction of post-hepatectomy liver failure in patients with hepatocellular carcinoma.

In the usability trial the clinicians and radiologists will be shown the counterfactual explanations and layerwise relevance propagation (LRP) plots to evaluate the usability of the framework.

In the clinical trial the clinicians and radiologists will make the prediction under two different conditions: with model explanation and without model explanation with a washout period of at least 14 days to evaluate the clinical effectiveness of the explanation framework.

Post-hepatectomy liver failure (PHLF) is a severe complication after liver resection. It is important to develop an interpretable model for predicting PHLF in order to facilitate effective collaboration with clinicians for decision-making. Two-dimensional shear wave elastography (2D-SWE) is a liver stiffness measurement (LSM) technology that was proven to be useful in liver fibrosis staging. Therefore 2D-SWE shows the potential value for liver function assessment and PHLF prediction. 2D-SWE images display color-coded tissue stiffness map of liver parenchyma, with red representing a solid tissue (higher stiffness) and blue representing a soft tissue (lower stiffness). Routine analysis of 2D-SWE fails to fully utilize all information available in the images and also suffers from inter-observer variance in choosing the optimal quantification region.

Deep learning (DL) has demonstrated state-of-the-art performance on many medical imaging tasks such as classification or segmentation. However, despite significant progress in DL, the clinical translation of DL tools has so far been limited, partially due to a lack of interpretability of models, the so-called "black box" problem. Interpretability of DL systems is important for fostering clinical trust as well as timely correcting any faulty processes in the algorithms.

Here, the investigators present a novel interpretable DL framework (VAE-MLP) which incorporates counterfactual analysis for the explanation of 2D medical images and LRP for the explanation of feature attributions of both medical images and clinical variables.

The goal of this in-silico clinical trial is to learn about the usability and clinical effectiveness of an interpretable deep learning framework (VAE-MLP) using counterfactual explanations and layerwise relevance propagation for prediction of post-hepatectomy liver failure (PHLF) in patients with hepatocellular carcinoma. The main questions it aims to answer are:

* To investigate the usability of the the interpretable deep learning framework (VAE-MLP) for explanation of the deep learning model.
* To investigate the clinical effectiveness of the interpretable deep learning framework (VAE-MLP) for prediction of post-hepatectomy liver failure in patients with hepatocellular carcinoma.

In the usability trial the clinicians and radiologists will be shown the counterfactual explanations and layerwise relevance propagation plots of 6 examples. The score of the Likert scale of a designed questionnaire is used to evaluate the usability of the framework.

In the clinical trial the clinicians and radiologists will make the prediction under two different conditions: with model explanation and without model explanation with a washout period of at least 14 days. The accuracy, sensitivity and specificity is used to compare the clinical effectiveness of the explanation framework.

Usability and Clinical Effectiveness of an Interpretable Deep Learning Framework for Post-Hepatectomy Liver Failure Prediction

Usability and Clinical Effectiveness of an Interpretable Deep Learning Framework (VAE-MILP) Using Counterfactual Explanations and Layerwise Relevance Propagation Framework for Post-Hepatectomy Liver Failure Prediction

Individual participant data (IPD) can be shared if asked

The accuracy, sensitivity and specificity will be compared between the prediction made with and without the explanation of the DL model to determine the clinical effectiveness of the explanation framework.

The score of the Likert scale of a designed questionnaire is used to evaluate the usability of the framework. Each item is given a score from 1 to 5. Higher scores mean a better outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis	NCT02676752	Lymphedema	Medical Examina... Questionnaire A... Shear Wave Elas...	22 Years -	Vanderbilt-Ingram Cancer Center
Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors	NCT02156700	Haemangioma Metastases Cholangiocellul... Hepatocellular ... Focal Nodular H...	Shear wave elas...	18 Years -	University Hospital Dubrava
Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy	NCT03013413	Prostate Carcin...	Shear Wave Elas... Ultrasound Elas... Ultrasound-Guid...	18 Years -	Thomas Jefferson University
Utility of Contrast-Enhanced Sonography and Shear Wave Elastography	NCT04614389	Thyroid Nodule	Contrast-enhanc... Shear Wave Elas... Sequoia System	18 Years - 70 Years	University of Southern California
Shear Wave Elastography of Rectal Adenomas and Cancer	NCT04409990	Rectal Neoplasm... Elasticity Imag...	Shear Wave Elas...	-	Vejle Hospital
Shear Wave Elastography Assessment of Neoadjuvant Chemotherapy Response in Patients With Invasive Breast Cancer	NCT05068999	Breast Neoplasm...	shear wave elas...	-	Assiut University
Investigation of Effects of Physiotherapy Interventions on Mechanical Properties of Muscle in Head and Neck Cancer	NCT05399953	Head and Neck C... Spinal Accessor... Thyroid Cancer Scapular Dyskin... Cervical Pain Shoulder Pain	Myofascial Rele... Exercise Scar Tissue Mas...	18 Years -	Yeditepe University
Usability and Clinical Effectiveness of an Interpretable Deep Learning Framework for Post-Hepatectomy Liver Failure Prediction	NCT06031818	Post-hepatectom... Hepatocellular ... Artificial Inte...	The explanation... The model predi... The model predi...	-	Maastricht University
Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy	NCT03013413	Prostate Carcin...	Shear Wave Elas... Ultrasound Elas... Ultrasound-Guid...	18 Years -	Thomas Jefferson University
Shear Wave Elastography Assessment of Neoadjuvant Chemotherapy Response in Patients With Invasive Breast Cancer	NCT05068999	Breast Neoplasm...	shear wave elas...	-	Assiut University
Utility of Contrast-Enhanced Sonography and Shear Wave Elastography	NCT04614389	Thyroid Nodule	Contrast-enhanc... Shear Wave Elas... Sequoia System	18 Years - 70 Years	University of Southern California

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