Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Tongue Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Tongue Diseases

Tongue Cancer

Oral Cancer

3D ultrasound scanning of the resected tongue tumor will be performed. The margin analysis will be made using the 3D ultrasound image.

3D ultrasound

Fatemeh Makouei

Tobias Todsen

Tobias Todsen, MD, PhD

Complete removal of cancer encircled by a secure margin of healthy tissue is the aim of surgical oncology. A close or positive surgical margin reported by pathologist typically ends in adjuvant therapies (re-surgery and/or radiotherapy), which come with prognostic risks and financial cost. Therefore, ex-vivo imaging of removed cancer tissue may assist in margin evaluation. In this study, investigators aimed to investigate the correlation of 3D ultrasound to histopathology to assess tongue tumor margin status.

Surgical Margin Assessment by 3D Ultrasound

Feasibility of 3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Histopathology

The smallest margin will be measured in mm on 3D ultrasound image of the ex-vivo surgical specimen. Correlation of the measurement to the final histopathology result will be investigated.

number of margins correctly classified as free (\> 5 mm), close (\< 5 mm) or positive (\<1 mm) margin

Rigshospitalet, Denmark

Biomedical Engineer, PhD

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Patients undergoing gynecological brachytherapy, will be imaged with a 3D ultrasound medical device for the purpose of efficacy testing.

Standard of care in interstitial or intracavitary brachytherapy is to insert the brachytherapy needle and applicator with no standard real-time image guidance. Interstitial brachytherapy is done under general anesthesia. Trans-abdominal and trans-rectal standard 2D ultrasound is used in some cases, but is typically not consistent and therefore its value is limited. Pre-procedure imaging in the form of MRI is used to help guide needles insertion as well as the clinical exam. Post-procedure CT is done for radiation planning

Interstitial and intracavitary brachytherapy

David D'Souza, MD

Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial and intracavitary brachytherapy is often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial brachytherapy is based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. The investigators propose a 3D ultrasound device that will provide real-time imaging for the brachytherapy procedure which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.

This is an efficacy study to optimize the use of three-dimensional ultrasound imaging for interstitial and intracavitary brachytherapy. In this study, 3DUS images will be acquired during the regular clinical procedure to assess the quality of the images, anatomical detail and location of needles. The acquired images will be analyzed post-treatment and fused with pre-treatment MRI, and post-treatment CT scans to develop a virtual simulated radiation treatment plan, and to verify the applicator positions.

Patients who are assigned to gynecological brachytherapy.

Females patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or intracavitary brachytherapy treatment.

Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2

The number of applicators identified within the 3D ultrasound image.

DICE coefficient of the tumour and needle applicators

Western University, Canada

Lip and Oral Cavity Cancer

3D ultrasound and MR scanning of the resected tongue tumor will be performed. The resected surgical specimen will also be examined by the surgeon to assess the margins. The accuracy of the margin assessment by 3D ultrasound, MRI, and surgeon examination will be evaluated by correlating the results to the final histopathology findings.

3D ultrasound, MRI, resected specimen examination by surgeon

Fatemeh Makouei, PhD

In the current protocol, application of 3D ex-vivo ultrasound, MRI, and clinical evaluation (palpation and examination) by the surgeon is proposed to analyze the margin status in tongue squamous cell carcinoma and correlate the results to the histopathology findings.

Cancer surgery is the primary treatment in the early stages of tongue squamous cell carcinoma (SCC), and the goal is the complete resection of the tumor with an adequate margin of healthy tissue around to ensure proper cancer removal. Inadequate margins lead to a high risk of local cancer recurrence and the patient will need re-surgery or adjuvant therapies. Ex-vivo imaging of the resected surgical specimen has been suggested to provide information for margin assessment and thus improve cancer surgery. In this manuscript, a protocol to investigate the clinical benefit of three-dimensional (3D) ultrasound imaging of the surgical margins and comparing the results to magnetic resonance imaging (MRI) and the clinical examination of the surgical specimen by surgeon (palpation to inspect the resected tissue) has been designed. Tumor segmentation and margin measurement (Anterior towards apex of tongue, posterior towards base of tongue, medial towards back of tongue, lateral towards floor of mouth, and profound/deep margins) will be performed by head and neck surgeons on 3D ultrasound images and by two consultant radiologists on MRI of the ex-vivo specimen. Accuracy of each method will be evaluated by computing the proportion of correctly classified margins (positive, close, and free) by each technique with respect to the gold standard histopathology.

3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment

3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Clinical Evaluation, MRI, and Histopathology

Biomedical Engineer, PhD, Assistant professor

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Myoma

Neoplasms, Connective and Soft Tissue

Doing 3D ultrasound for diagnosis of submucous myoma

3D Ultrasound

Doing hysteroscopy for diagnosis of submucous myoma

Hysteroscopy

Mahmoud Alalfy, PhD

• three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.

The speculum was removed and a 5 MHz transvaginal 3D ultrasound probe inserted into the vagina (Voluson 730; KretzTechnik, Austria).

3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas

How many women will be diagnosed by 3D US to have submucous myoma

Cairo University

Aljazeera Hospital

Device: Gynecological brachytherapy requiring an Interstitial or ring and tandem insert involves insertion of the needle and applicators with no standard real-time image guidance. Occasionally 2-dimensional ultrasound is used, but it greatly limited by its flat nature, preventing a volumetric view of the needle pathways. Interstitial brachytherapy is done under general anesthesia. The trans-abdominal and trans-rectal standard 2D ultrasound that are used in some cases, will be expanded to 3D dimensional imaging through the use of an investigational device. Pre-procedure imaging in the form of MRI is used to help guide needles insertion as well as the clinical exam. Post-procedure CT is done for radiation planning.

Management of gynecological malignancies is done through brachytherapy treatment, which involves the delivery of radiation via radioactive sources that are placed into or in close proximity to the tumour.

Gynecological brachytherapy

Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial or intra-cavitary brachytherapy are often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial or intra-cavitary brachytherapy are based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. We propose using 3D ultrasound to provide real-time imaging for the brachytherapy procedure, which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.

Patients who are assigned to gynecological brachytherapy

3DUS Imaging of Needles in Gynecological Brachytherapy

A Multi-Modality Comparison of Needle Placement During Gynecological Brachytherapy Procedures

Observed needle locations in 3-D TVUS and CT planning images are measured and compared.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Carcinoma, Renal Cell

Liver Neoplasms

Abdominal Neoplasms

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Hematinics

Liver Extracts

Cancer patients who are scheduled to undergo an ablation or biopsy of a liver or kidney tumour

The medical device will passively record image data during the standard care ablation

Ablation

The medical device will passively record image data during the standard care biopsy

Biopsy

Aaron Fenster

Derek Cool, MD/PhD

This study is to assess the addition of 3D ultrasound guidance during standard care ablation or biopsies of liver or kidney tumours. 3D ultrasound only differs from conventional 2D ultrasound in that the ultrasound transducer is mounted on a special assembly that moves the transducer in precise, stepped movements while a succession of 2D images are collected by the computer. Special software written specifically for 3D ultrasound precisely aligns these 2D images into a 3-demensional volume , allowing area in question to be viewed in many different planes. 3D ultrasound is a safe, fast, non-invasive imaging procedure. Ultrasound images will be checked against the pre- and post- procedure CT images to make sure the tumours were completely removed or properly targeted during biopsy.

Images will be acquired by a physician on patients who are undergoing a liver or kidney ablation or biopsy procedure who are well enough to provide consent. Patients will be imaged during the ablation procedure according to the standard of care, and subsequent analysis will commence following the acquisition. The devices being used are all property of the LHSC health network that have been licensed for clinical use through Health Canada. In addition, 3D ultrasound only differs from conventional 2D ultrasound in that the ultrasound transducer is mounted on a special assembly that moves the transducer in precise, stepped movements while a succession of 2D images are collected by the computer. Special software written specifically for 3D ultrasound precisely aligns these 2D images into a 3-dimensional volume, allowing the area in question to be viewed in different planes. The clinical 2D an d3D ultrasound images will be checked against the pre- and post- procedure CT images to make sure the tumours were completely removed.

(3D) Ultrasound Imaging Liver and Kidney

Use of 3-Dimensional (3D) Ultrasound Imaging to Guide the Treatment of Abdominal Tumours Using Focal Ablation or Biopsies

The objective of this study is to use 3D ultrasound in addition to standard care ultrasound to guide the ablation needles in destroying focal tumours within the diseased organ

Symptoms and General Pathology

Endometrial Neoplasms

Hyperplasia

Endometrial Hyperplasia

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Genital Diseases

All patients with confirmed endometrial cancer will recieve the gold standard pre-operative imaging (MRI) but will also be offered 3D ultrasound.

A 3D ultrasound will be performed for all patients presenting to the clinic for suspected endometrial cancer (in addition to routine standard of care)

Diana Marcus, MB BS

Joseph Yazbek, FRCOG

Joseph Yazbek, FRCOG PhD

Sadaf Ghaem-Maghami, FRCOG PhD

Aim: Assess the diagnostic accuracy of 3D Ultrasound, compared to MRI and final histology with respect to myometrial invasion of endometrial cancer.

This study will assess whether 3D ultrasound is accurate at predicting myometrial invasion aqnd lymph node metastasis of endometrial cancer. All patients will receive routine standard of care (MRI). The results of the 3D ultrasound will be compared to the MRI report and final histology.

Aim:

Assess the diagnostic accuracy of 3D Ultrasound, compared to MRI and final histology with respect to myometrial invasion of endometrial cancer.

Background:

When a diagnosis of endometrial cancer is confirmed on biopsy, women get staged to assess the level of spread. Current gold standard is an MRI. A proportion of women, are unable to undergo or complete an MRI scan due to their morbid obesity or claustrophobia. To this end, many have assessed the role of ultrasound in staging endometrial cancer as a cheaper and easier alternative to an MRI. In the last 20 years there has been a rise in the use of 3D ultrasound as it has become commercially available. There is, however a paucity of data on the role of 3D ultrasound in the assessment of myometrial invasion and lymph node metastasis. This research project will assess whether 3D ultrasound is a safe, effective alternative to MRI to assess the depth of spread of womb cancer.

The study:

All women with suspected endometrial cancer will receive a pelvic (internal) ultrasound as per routine care. In addition to the normal 2D ultrasound, women will receive a 3D ultasound and images will be saved. This adds an additional 1-2 minutes scan time.

In those women with confirmed cancer on histology an MRI is performed to assess stage of cancer (current routine standard of care). This will include T1, T2, DWI and contrast enhanced sequences. Patients referred to Hammersmith Hospital from other trusts will also be able to undergo a 3D ultrasound if this was not already performed. Definitive management of endometrial cancer includes a hysterectomy and the surgical specimen will be examined for depth of myometrial invasion and lymph node involved (if removed). In the meantime, the saved 3D ultrasound images will be analysed and rendered to predict the stage of the endometrial cancer and lymph node involvement. The results of 3D ultrasound, and MRI will be compared against the stage found on the gold standard test (on histological examination).

Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?

Sensitivity, specificity, negative and positive predictive value in diagnosing myometrial invasion.

Measuring 3D volume of tumour and assess if correlation with lymph node metastasis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgical Margin Assessment by 3D Ultrasound	NCT05740774	Tongue Cancer Squamous Cell C... Head and Neck C...	3D ultrasound	18 Years -	Rigshospitalet, Denmark
Surgical Margin Assessment by 3D Ultrasound	NCT05740774	Tongue Cancer Squamous Cell C... Head and Neck C...	3D ultrasound	18 Years -	Rigshospitalet, Denmark
Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2	NCT04336683	Gynecologic Can...	Interstitial an...	18 Years -	Western University, Canada
3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment	NCT05843032	Squamous Cell C... Tongue SCC Head and Neck C...	3D ultrasound, ...	18 Years -	Rigshospitalet, Denmark
3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas	NCT04736095	Fibroid	3D Ultrasound Hysteroscopy	20 Years - 60 Years	Aljazeera Hospital
3DUS Imaging of Needles in Gynecological Brachytherapy	NCT04705467	Gynecologic Can...	Gynecological b...	18 Years -	Western University, Canada
(3D) Ultrasound Imaging Liver and Kidney	NCT03844399	Liver Cancer Kidney Cancer	Ablation Biopsy	18 Years -	Western University, Canada
3DUS Imaging of Needles in Gynecological Brachytherapy	NCT04705467	Gynecologic Can...	Gynecological b...	18 Years -	Western University, Canada
Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2	NCT04336683	Gynecologic Can...	Interstitial an...	18 Years -	Western University, Canada
Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?	NCT03207061	Endometrial Can... Endometrial Neo... Endometrial Hyp...	3D Ultrasound	18 Years -	Imperial College London
3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas	NCT04736095	Fibroid	3D Ultrasound Hysteroscopy	20 Years - 60 Years	Aljazeera Hospital
(3D) Ultrasound Imaging Liver and Kidney	NCT03844399	Liver Cancer Kidney Cancer	Ablation Biopsy	18 Years -	Western University, Canada

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