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OpenTrials
Active, Not Recruiting

NCT Number: NCT05336786

Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Amsterdam University Medical Centers, Amsterdam, Netherlands

Loading trial locations.

About this study

PRIMARY OBJECTIVES:

I. To collect multiparametric ultrasound (mp-US) data on 70 patients within 30 days of their radical prostatectomy.

II. To correlate the imaging data with whole mount prostatectomy specimens in order to optimize mp-US with a machine learning approach.

OUTLINE:

Patients receive perflutren lipid microspheres intravenously (IV) over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres during ultrasound.

After completion of study, patients are followed up for 30 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Participant in a clinical trial involving an investigational drug within the past 30 days
  • Patients with known or suspected hypersensitivity to perflutren, PEG, or any other component of Definity
  • Previous treatment for prostate cancer, including hormone therapy
  • Clinically unstable, severely ill, or moribund as per treating physician

Treatment and study plan

Perflutren Lipid Microspheres

Drug

Given IV

Other names: Definity

Ultrasound

Procedure

Undergo ultrasound

Primary outcomes

  1. Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2022
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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