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NCT05336786Active, not recruitingPhase 3

Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

Source: ClinicalTrials.gov · Last updated 4 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
70 (actual)
First submitted
7 Apr 2022
Start date
15 Jun 2022
Primary completion date
26 May 2025
Lead sponsor
Thomas Jefferson University
NCT number
NCT05336786

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 70
  • From 15 Jun 2022 to the primary completion date, 26 May 2025
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant in a clinical trial involving an investigational drug within the past 30 days
  • Previous treatment for prostate cancer, including hormone therapy

Other illness

  • Patients with known or suspected hypersensitivity to perflutren, PEG, or any other component of Definity

Other

  • Clinically unstable, severely ill, or moribund as per treating physician

Who the study is looking for

  • Subject must be scheduled for radical prostatectomy for treatment of prostate cancer
  • Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate prior to prostatectomy
  • Subject must be a male at least 18 years of age when informed consent is obtained

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amsterdam University Medical Centers
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Sidney Kimmel Cancer Center at Thomas Jefferson University
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.