Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

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

Shear Wave Elastography

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

Digestive System Diseases

Rare Diseases

Liver Neoplasms

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Primary Liver Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients undergo ultrasound elastography.

ultrasound elasticity imaging

Juergen Willmann

This clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions.

PRIMARY OBJECTIVES:

I. To determine the utility of ultrasound elastography in correlation with kidney or liver biopsy or magnetic resonance imaging (MRI) or computed tomography (CT) results.

OUTLINE:

Patients undergo ultrasound elastography.

Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions

US Elastography for Characterizing Focal Lesions in the Liver and Kidney

Suspicious liver and kidney lesions will be analyzed separately on a per-lesion basis. Within each population, the strain ratio of cases and controls will be compared using the Wilcoxon rank sum test, and the analysis will be illustrated using the non-parametric receiver operating characteristic (ROC).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions	NCT01908166	Adult Primary L... Kidney Tumor	ultrasound elas...	19 Years -	Stanford University
Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions	NCT01908166	Adult Primary L... Kidney Tumor	ultrasound elas...	19 Years -	Stanford 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

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