A Pilot Trial of Sonoelastography for Planning Tumor-targeted Prostate Biopsy

NCT01748890 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-10-20

Study results available
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Summary

Prostate cancer is the most common cancer and the second-leading cause of cancer death amongst men in the United States. Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. It permits measurement of the elastic properties of tissue. These measurements can be transposed onto conventional anatomic ultrasound images, producing a colorized overlay that allows direct visualization of the anatomic distribution of tissue stiffness. In this study, we aim to determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to intersect with foci of carcinoma in the prostate gland, and to determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to yield histopathology representative of the final Gleason Score obtained at pathologic assessment of the resected prostate.

Conditions

Interventions

DEVICE

Sonoelastography

Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Anthony E. Samir, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01748890 on ClinicalTrials.gov