Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

Prostate Carcinoma Clinical Trial

Official title:

Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336786
• Other study ID #: 21G.1212
• Status: Recruiting
• Phase: Phase 3
• Start date: June 15, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: Flemming Forsberg, PhD
• Phone: 215-955-4870
• Email: flemming.forsberg[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2024
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Drug:
• Perflutren Lipid Microspheres
Given IV

Procedure:
• Ultrasound
Undergo ultrasound

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Centers	Amsterdam
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate		Up to 12 months