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Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

NCT05336786 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-09-04

No results posted yet for this study

Summary

This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.

Conditions

  • Prostate Carcinoma

Interventions

DRUG

Perflutren Lipid Microspheres

Given IV

PROCEDURE

Ultrasound

Undergo ultrasound

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2025-05-26
Completion
2026-05-26
FDA Drug
Yes

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

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 NCT05336786 on ClinicalTrials.gov