Using ultrasound with contrast agent to diagnose prostate cancer
Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
PHASE3 · Thomas Jefferson University · NCT05336786
This study is testing if a special ultrasound dye can help doctors better see and diagnose prostate cancer in patients who are having surgery.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Thomas Jefferson University (other) |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT05336786 on ClinicalTrials.gov |
What this trial studies
This phase III trial investigates the use of perflutren lipid microspheres, an ultrasound contrast agent, to non-invasively diagnose prostate cancer. The study aims to collect multiparametric ultrasound data from 70 patients scheduled for radical prostatectomy and correlate this imaging data with whole mount prostatectomy specimens. By enhancing ultrasound images of the prostate, the study seeks to improve the identification of prostate cancer using a machine learning approach. Patients will receive the contrast agent intravenously and undergo ultrasound imaging, followed by a 30-day follow-up.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older who are scheduled for radical prostatectomy due to prostate cancer.
Not a fit: Patients who have previously received treatment for prostate cancer or have known hypersensitivity to the contrast agent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method for diagnosing prostate cancer, potentially leading to earlier detection and treatment.
How similar studies have performed: Other studies using ultrasound contrast agents have shown promise, but this specific approach is novel and untested in the context of prostate cancer diagnosis.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (RECRUITING)
- Amsterdam University Medical Centers — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Flemming Forsberg, PhD
- Email: flemming.forsberg@jefferson.edu
- Phone: 215-955-4870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Carcinoma