Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05336786
Study type	Interventional
Source	Thomas Jefferson University
Contact	Flemming Forsberg, PhD
Phone	215-955-4870
Email	flemming.forsberg@jefferson.edu
Status	Recruiting
Phase	Phase 3
Start date	June 15, 2022
Completion date	August 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04457232` - Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation	Phase 1
Active, not recruiting	`NCT03661437` - Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy	Early Phase 1
Completed	`NCT02337465` - KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer	N/A
Completed	`NCT03013413` - Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy	N/A
Recruiting	`NCT06037863` - Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial	N/A
Active, not recruiting	`NCT03580499` - Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy	N/A
Completed	`NCT03326440` - Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer	N/A
Recruiting	`NCT04597359` - To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring	Phase 2
Active, not recruiting	`NCT03263650` - Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC	Phase 2
Active, not recruiting	`NCT04600336` - Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer	Phase 2
Active, not recruiting	`NCT04299620` - Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy	N/A
Completed	`NCT04976257` - Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion	Early Phase 1
Completed	`NCT02957981` - The Genetic Education for Men Trial: Web-Based Education vs. Standard Care	N/A
Withdrawn	`NCT03408561` - Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer	N/A
Enrolling by invitation	`NCT06347809` - DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
Enrolling by invitation	`NCT04254133` - Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
Recruiting	`NCT05519878` - Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers	N/A
Recruiting	`NCT02994758` - Development of Diagnostics and Treatment of Urological Cancers	N/A
Completed	`NCT01497431` - Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants	Phase 1
Active, not recruiting	`NCT00002540` - Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)	N/A