Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

March 7, 2024 updated by: Flemming Forsberg, Thomas Jefferson University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To collect multiparametric ultrasound (mp-US) data on 50 patients > 3 days prior to 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Not yet recruiting
        • Amsterdam University Medical Centers
        • Contact:
          • H.P. Beerlage, MD
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Sidney Kimmel Cancer Center at Thomas Jefferson University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (perflutren lipid microspheres, ultrasound)
Patients receive perflutren lipid microspheres IV over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres
Procedure: Ultrasound
Undergo ultrasound
Drug: Perflutren Lipid Microspheres
Given IV
Other Names:
  • Definity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Estimated)

June 26, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 14, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21G.1212

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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