Heart and Blood Diseases

All Conditions

Symptoms and General Pathology

Thrombosis

Venous Thrombosis

Postoperative Complications

Embolism

Embolism and Thrombosis

Vascular Diseases

Anticoagulants

All Drugs and Chemicals

Fibrinolytic Agents

Anti-Infective Agents

Amino Acids

PENTA

Fondaparinux

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.

Patients randomized to treatment arm will initiate Arixtra (fondaparinux sodium) treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization time and after hospital discharge).

Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.

Arixtra (fondaparinux sodium)

Intermittent compression devices (ICD)

Warner K. Huh, M.D.

This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.

To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.

Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy

Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra (Fondaparinux Sodium): A Randomized Controlled Trial

Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.

Adverse events will be evaluated to determine untoward effects.

GlaxoSmithKline

University of Alabama at Birmingham

Principal Investigator

Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.

Intermittent Compression Devices

Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)

Arixtra (Fondaparinux Sodium)

Fondaparinux (Arixtra)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

This trial was terminated early due to poor enrollment and recruitment and the very small number of subjects analyzed. As such, the data is uninterpretable.

Warner K. Huh, MD

Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.

Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)

Planned Intention to Treat analysis but was unable to complete due to inadequate number of subjects enrolled.

Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra

Incidence of Untoward Effects With Arixtra

Overall Study

Antineoplastic Agents

Immune Checkpoint Inhibitors

Immunomodulating Agents

Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks.

Power Doppler measurements will be made using a portable Siemens S2000 or S3000 ultrasound scanner

Doppler ultrasound

Long Ensemble Angular-coherence Doppler measurements will be made using a Verasonics Vantage 256 scanner

Long Ensemble Angular-coherence Doppler [LEAD] ultrasound

Contrast-enhanced ultrasound measurements will be made using Lumason IV contrast injection followed by an injection of normal saline

Contrast-enhanced ultrasound (CEUS)

Christian R Hoerner

Christian Hoerner

Alice Fan, M.D

Alice C. Fan, MD

Jeremy Dahl, Ph.D

Aya Kamaya, M.D

Primary objective is to assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by CEUS, can predict initial objective response to therapy, defined by current standard-of-care

Secondary objectives are to evaluate if there is an optimal ultrasound imaging modality (CEUS or conventional power Doppler or LEAD ultrasound) or optimal time point to predict initial objective response and to assess the correlation of tumor perfusion parameters with change in overall tumor burden, change in diameter on a per-lesion basis, and with 12-month progression-free survival (PFS).

Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy

Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1

defined as relative change in the sum of diameters of all measurable tumors, assessed between treatment 'baseline' and first on-treatment response evaluation

defined as the relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation

defined as not having experienced any PD per RECIST v1.1

Stanford University

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Multiparametric ultrasound of the breast including elastography, color/power Doppler, contrast agent application and 3D sonography.

Ultrasound of the breast

Despite advances in mammographic technique, mammography is limited in the detection and diagnosis of breast lesions with respect to sensitivity and specificity. In recent decades, ultrasound has become an essential adjunct to mammography for the further characterization of mammographically detected or palpable lesions or in the diagnosis of patients with dense breasts.

However, in spite of defined morphological criteria for the differentiation of benign from malignant lesions, ultrasound of the breast also shows limitations regarding sensitivity and specificity. On the one hand, benign lesions may have one or more malignant characteristics and thus require a biopsy. On the other hand, malignant lesions can also show benign characteristics and thus make an accurate assessment difficult.

To overcome these limitations, newer sonographic methods have been developed. These include elastography, color and power Doppler imaging, contrast enhanced imaging and 3D sonography.

The application of elastography is based on the fact that cancer has a higher stiffness than healthy breast parenchyma.

In addition, cancers are characterized by neoangiogenesis and thus generally show an increased vascularization in color and power Doppler. The detection of neoangiogenesis can be improved by the application of contrast agents. The latter provides both morphological and functional information about tumors, through the study of the contrast agent kinetics.

Finally, 3D sonography allows for tumors to be examined in a third, coronal plane. This way, the interaction between the tumor and the surrounding healthy tissue can be better appreciated.

The objective of this study is the evaluation of suspicious (classified as BI-RADS 4 and 5) breast lesions by using high-resolution sonography, including elastography, color/power Doppler, contrast agent application and 3D sonography. Both morphological and functional information can thus be obtained. The primary hypothesis of this study is that this multiparametric approach will improve the detection and characterization of breast lesions.

Multiparametric High-resolution Ultrasound of the Breast

Multiparametric High-resolution 3-D Sonography With Color/Power-Doppler, Elastography and Contrast-enhanced Sonography for an Improved Detection and Characterization of Breast Tumors

H0: There is no difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques.

H1: There is a difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques.

Medical University of Vienna

M.D.

Breast Diseases

Skin Diseases

Female patients with breast tumors and/or axillary lymph node metastases who had markers placed before neoadjuvant chemotherapy (NACT), and patients undergoing preoperative marker localization after NACT

Before neoadjuvant chemotherapy (NACT) in cases of locally advanced breast cancer, malignant masses in the breast and biopsy-proven tumor involvement axillary lymph nodes are marked with metallic markers. The primary objective of this marking is to establish the precise localization of the tumor which response to NACT partial or completely. However, selecting the marker with ultrasound (US) proves challenging in many instances. Research studies indicate that patients with occult markers are observed at a frequency of 24%. Some studies propose that the twinkling artifact serves as a reliable method for accurately indicating the localization of certain tumor markers. This artifact is deemed particularly helpful for lesions situated in the axilla or posterior of the breast, which may not be visible with US and are undetectable with mammography.

In the context of Color Doppler examination, the investigators have noted the presence of another color Doppler artifact which can aid in determining marker localization. When the pulse repetition frequency (PRF) is reduced and the color gain is increased, color noise, termed as color confusion or blooming artifact/effect, is observed within the color steer. While this color confusion tends to mask healthy tissues, it has been observed that the tumor marker remains unaffected by the blooming effect. Consequently, this artifact serves to distinctly reveal the borders and localization of the tumor marker.

In some studies, it has been stated that the twinkling artifact, which is a color Doppler artifact and whose mechanism is not fully understood, is a reliable method to accurately indicate the localization of some tumor markers. It has been reported that this artifact will be very helpful, especially in lesions located in the axilla or posterior of the breast, which cannot be seen with US and cannot be detected with mammography .

In Color Doppler examination, we saw that another color Doppler artifact, such as the twinkling artifact, could also be helpful in determining marker localization. When the PRF is reduced and the color gain is increased, color noise, which is selected as color confusion and can be called blooming artifact or blooming effect-like, is observed in all structures within the color steer. While healthy tissues are masked by this color confusion, the tumor marker is protected from the blooming effect. Thus, with this artifact, tumor marker borders and localization are clearly revealed.

Following an exhaustive review of the existing literature, the investigators have determined that their study stands as the first to show the utility of like blooming artifact appearance in color Doppler US for precisely determining the localization of tumor markers placed in the breast and axilla. There are two crucial phases in this study: Pre and post-NACT patients. In these two stages, tumor markers could be successfully demonstrated using this artifact (blooming artifact-like appearance). This groundbreaking finding lends support to B-mode ultrasound (US), which demonstrates high diagnostic potential and proves valuable for radiologists, thereby providing reassurance Post-NACT, the hypoechoic mass in the breast and the thick-cortical lymph node in the axilla undergo shrinkage. Identifying the residual mass becomes feasible solely with the hyperechoic marker placed before NACT. The hyperechoic marker in the shrinking mass after NACT cannot be discerned from the hyperechoic fibrous structures in the normal breast parenchyma. However, when the like blooming artifact is generated in the color Doppler examination, the echogenic normal breast or axillary parenchyma is enveloped by this artifact. Importantly, the metallic marker remains unaffected by this artifact.

To achieve homogeneity of this artifact, specific Doppler US parameters must be applied to the color Doppler examination window. For this artifact to be diagnostic, color Doppler US must be provided in the all examination consistently. Consequently, while the non-marker area is covered with the blooming artifact, the marker becomes distinctly visible.

The investigators note that while the use of twinkling artifacts in determining marker localization is well-established, the blooming artifact utilized in this study remains unknown. No prior literature research has explored this artifact or highlighted its diagnostic contributions.

In this study, the investigators have aimed to mask tissues outside the marker with the blooming artifact. Consequently, the linear marker cannot be masked and appears echogenic. In the color Doppler US window covered with the blooming artifact, only the marker itself stands out as a smooth linear echogenicity. This distinctive feature enables an easy examination for determining marker localization, irrespective of the marker's structure, shape, or ambient temperature. Therefore, it can be asserted that this method is not only easier to implement but also more reliable compared to other techniques.

Using Color Doppler US Artifact to Identify Tumor Markers

Using Color Doppler US Artifact to Identify Localization of Breast and Axilla Tumor Markers

Use of Doppler US artifacts as an auxiliary diagnostic method in cases where tumor markers in the breast and axilla cannot be detected with conventional US.

Istanbul Medeniyet University

Assistant professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Erectile Dysfunction

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Sexual Dysfunction, Physiological

Male Urogenital Diseases

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Genital Neoplasms, Male

Urogenital Neoplasms

Prostatic Diseases

Quality of Life

Patients with prostate cancer who will undergo radical prostatectomy

Basal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy

Jesus Muñoz-Rodriguez, MD

A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using Doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. The baseline study will be compared with the study one year after surgery.

Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy

Valuation Of Vascular Changes And Their Impact On Erectile Function By Penile Doppler Ultrasound And Analysis Of The Quality Of Life Of Patients Undergoing Laparoscopic Radical Prostatectomy

Corporacion Parc Tauli

Medical Doctor

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Endothelial Growth Factors

Mitogens

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Antineoplastic Agents, Immunological

Tyrosine

Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)

Patients are planned to be treated with non-ICI therapy

Doppler Ultrasound

Vantage 256 used for power doppler ultrasound, manufactured by Verasonics

SIEMENS S3000 and Verasonics Vantage 256

Participants will receive less than 4 weeks of TKI treatment during the first 12 weeks. Plus immune checkpoint inhibitor (arm 1) or non-immune checkpoint inhibitor (arm 2)

Vascular Endothelial Growth Factor Receptor 2 tyrosine kinase inhibitor plus immune checkpoint inhibitor

Alice C Fan, MD

Jeremy Dahl, PhD

To assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by power Doppler ultrasound, can predict initial objective response, defined by current standard-of-care, to therapy at 12 weeks after start of treatment

Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Early Therapeutic Monitoring of Response to Therapy With Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)

Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1 at first on-treatment response evaluation 8-16 weeks after initiating treatment. The results will be expressed as number without dispersion.

Relative change will be assessed as sum of all tumor diameters between treatment 'baseline' and first on-treatment response evaluation 8-16 weeks after start of treatment, using RECIST v1.1 for tumor diameter measurements, expressed as mean +/- standard deviation and median with interquartile range

Relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation 8-16 weeks after start of treatment, using RECIST v1.1 for tumor diameter measurements, will be measured as mean +/- standard deviation and median with interquartile range.

PFS is defined as not having experienced any progressive disease (PD) per RECIST v1.1 within the first 12 months after initiating treatment (day 1 will be treatment start date), as a number and proportion without dispersion.

National Institutes of Health (NIH)

Tissue Doppler ultrasound on pediatric patients

Reham M Farghally

Duaa M Raafat

Reham Farghally

Duaa Raafat

Tissue Doppler assessment of right ventricular function in newly diagnosed pediatric cancer patients underwent chemotherapy in South Egypt Cancer Institute.

The incidence of cancer is always increasing and it is predicted that the incidence will increase to 45% by 2030(1). The introduction of new chemotherapeutic agents significantly improved survival, but also revealed large spectrum of cardiotoxicity manifestations (2). There are many factors that increase the risk of cardiotoxicity caused by different chemotherapeutic agents, such as type of chemotherapy, cumulative dose, concomitant or previous radiotherapy, and comorbidities (3). Chemotherapeutic regimens which contain anthracyclines, cyclophosphamide, fluorouracil, cisplatin, taxanes and trastuzumab cause early and late cardiotoxicity (4).

The majority of published studies are focused on left ventricle dysfunction in patients receiving cardiotoxic chemotherapy. However, the right ventricle has been ignored for a long time and a little attention has been directed to show the effect of chemotherapy on right ventricle function. Right ventricle dysfunction is associated with increased morbidity and mortality in many cardiovascular diseases (5). The structure of cardiomyocytes and blood supply between the left and right ventricles are similar. Given the smaller mass and fewer myofibrils of right ventricle, chemotherapy may theoretically cause a more significant impact on it (6).

The right ventricle has a complex geometric shape which includes smooth muscular inflow, outflow and a trabecular apical region so echocardiographic assessment of right ventricle is difficult (7).

M-mode echocardiography, two-dimensional echocardiography, conventional Doppler echocardiography, and myocardial Doppler tissue imaging are all used to evaluate right ventricular function and provide accurate prognostic information especially when used in combination

Tissue Doppler Assessment of Right Ventricle Function in Pediatrics Underwent Chemotherapy

Tissue Doppler Assessment of Right Ventricular Function in Newly Diagnosed Pediatric Cancer Patients Underwent Chemotherapy in South Egypt Cancer Institute

The correlation between echocardiographic parameters of the RV, measured with transthoracic echocardiography before and after chemotherapy

Assiut University

Resident

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.

Shear-Wave Elastography

Antonia E. Stephen, MD

As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing surgery will have benign lesions verified by histopathology after surgery.

Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a result these subjects will have had surgery for diagnosis of a benign lesion.

The aim of this study is to see whether shear-wave elastography, a new ultrasound technology can help pre-operatively diagnose benign follicular lesions. If successful, a lot of patients will not need surgery for the diagnosis of a benign lesion.

The main goal of this study will be to evaluate the diagnostic accuracy of a new ultrasound technology, shear-wave elastography (SWE), for the diagnosis of malignancy in follicular lesions. Participants who have been diagnosed with a follicular lesion on thyroid biopsy and are scheduled for thyroid surgery will be eligible to participate. All participants will undergo a detailed ultrasound examination prior to their surgery. The results of the ultrasound will be compared with histopathology after surgery to test the diagnostic accuracy of SWE.

Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid

A Multivariate Analysis of Factors Predictive of Carcinoma in Follicular Neoplasms of the Thyroid Gland

Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery.

Massachusetts General Hospital

Assistant Professor of Surgery

Antonia Stephen, MD

Transverse Plane

Sagittal Plane

Transverse Plane with Nodule in the Center

Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort includes all participants with benign lesions.

Shear-Wave Elastography, Benign Lesions

Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort Includes all participants with malignant lesions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy	NCT00539942	Venous Thrombos...	Arixtra (fondap... Intermittent co...	19 Years - 85 Years	University of Alabama at Birmingham
Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy	NCT05206942	Solid Tumor	Doppler ultraso... Long Ensemble A... Contrast-enhanc...	18 Years -	Stanford University
Multiparametric High-resolution Ultrasound of the Breast	NCT03276845	Breast Cancer	Ultrasound of t...	18 Years - 99 Years	Medical University of Vienna
Using Color Doppler US Artifact to Identify Tumor Markers	NCT06166173	Breast Cancer Interventional ... Doppler Ultraso...		-	Istanbul Medeniyet University
Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy	NCT03241758	Prostatic Neopl... Erectile Dysfun...	Doppler ultraso...	18 Years - 80 Years	Corporacion Parc Tauli
Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)	NCT04508725	Kidney Cancer Renal Cell Carc... Metastatic Rena...	Doppler Ultraso... SIEMENS S3000 a... Vascular Endoth...	18 Years -	Stanford University
Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy	NCT05206942	Solid Tumor	Doppler ultraso... Long Ensemble A... Contrast-enhanc...	18 Years -	Stanford University
Tissue Doppler Assessment of Right Ventricle Function in Pediatrics Underwent Chemotherapy	NCT04831359	Pediatric Cance...	Doppler ultraso...	1 Year - 16 Years	Assiut University
Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)	NCT04508725	Kidney Cancer Renal Cell Carc... Metastatic Rena...	Doppler Ultraso... SIEMENS S3000 a... Vascular Endoth...	18 Years -	Stanford University
Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid	NCT03106337	Thyroid Nodule Follicular Neop...	Shear-Wave Elas...	18 Years -	Massachusetts General Hospital
Incidence and Clinical Progression of Asymptomatic PICC-Related Thrombosis in Solid Cancer Patients	NCT05966909	Catheter Relate...	Doppler Ultraso...	18 Years - 90 Years	Azienda Ospedaliera Universitaria Integrata Verona

Spots Global Cancer Trial Database for doppler ultrasound