Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

Thomas Jefferson University

Status and phase: Active, not recruiting; Phase 3

Conditions: Prostate Carcinoma

Treatments: Drug: Perflutren Lipid Microspheres; Procedure: Ultrasound

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05336786

JT 18100 (Other Identifier)

R01CA252311 (U.S. NIH Grant/Contract)

21G.1212

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Diagnostic (perflutren lipid microspheres, ultrasound)

Experimental group

Description:

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

Treatment:

Procedure: Ultrasound

Drug: Perflutren Lipid Microspheres