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Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study

NCT02967458 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-04-30

Study results available
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Summary

This is a phase II single center study using contrast-enhanced ultrasound to identify aggressive forms of prostate cancer with subharmonic imaging.

The following are the study objectives:

1. To implement subharmonic imaging technology on a transrectal probe suitable for prostate imaging and biopsy
2. To demonstrate visualization of prostatic vascularity using subharmonic contrast-enhanced imaging.
3. To provide a preliminary estimate of the diagnostic accuracy of contrast-enhanced subharmonic imaging for detection of clinically significant PCa.

The study will include 50 subjects who are scheduled for prostate biopsy. Each subject will receive an intravenous infusion of microbubble contrast material immediately prior to a prostate biopsy procedure. The study will demonstrate whether subharmonic imaging with a microbubble contrast agent allows for detection of clinically significant prostate cancer.

Conditions

  • Prostatic Neoplasm

Interventions

DRUG

Perflutren Lipid Microsphere Intravenous Suspension

The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used to guide targeted biopsy of the prostate to vascular areas which are more likely to contain aggressive prostate cancer.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Ethan J Halpern, MD · Thomas Jefferson University

  • Flemming Forsberg, PhD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-02-01
Completion
2018-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02967458 on ClinicalTrials.gov