← Back to Search

Procedure

3-Tesla MRI for Prostate Cancer

N/A

Waitlist Available

Led By Michael Knopp, MD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Patients that have vascular or aneurysm clips, or metallic staples from a surgical procedure

Patients who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an MRI of the prostate done with a 3 Tesla magnet and an external body coil is as good as the standard 1.5 Tesla MRI with an endorectal coil in terms of helping doctors decide which approaches to disease therapy might be best for patients.

Who is the study for?

This trial is for patients with known or suspected prostate cancer, specifically those with a Gleason's score >= 7 and PSA > 10ng/dl. Participants must have proper kidney function (eGFR >= 30 mL/min/1.73m^2). They should be able to follow the study procedures and communicate effectively. Those with severe renal issues, bioimplants like pacemakers, metal in their body, or extreme anxiety are excluded.

What is being tested?

The trial tests if using a stronger magnet (3 Tesla MRI) without an uncomfortable internal coil can still provide clear images of the prostate for better treatment planning. It compares this method against standard imaging practices to see if it offers more comfort without compromising image quality.

What are the potential side effects?

There may not be direct side effects from the MRI itself; however, individuals might experience discomfort due to lying still during the procedure or anxiety from being in a confined space. The strong magnetic field requires exclusion of people with certain implants or metal fragments.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have metal clips or staples from surgery in my body.

Select...

I have heart problems or issues with blood circulation and sweating.

Select...

My kidney function is severely reduced.

Select...

I have kidney problems related to liver disease or after liver transplant surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (3T MRI)Experimental Treatment4 Interventions

Patients undergo 3T MRI, including DCE-MRI, diffusion-weighted MRI, amide-proton-transfer MRI, and MR spectroscopy scans. Patients may undergo an additional 3T MRI scan at least 24 hours after the initial scan.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

magnetic resonance spectroscopic imaging

2010

N/A

~230

dynamic contrast-enhanced magnetic resonance imaging

2006

Completed Phase 2

~470