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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil
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
~450
diffusion-weighted magnetic resonance imaging
2013
Completed Phase 1
~730
Find a Location
Who is running the clinical trial?
University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,114 Total Patients Enrolled
4 Trials studying Prostate Cancer
169 Patients Enrolled for Prostate Cancer
Ohio State University Comprehensive Cancer CenterLead Sponsor
322 Previous Clinical Trials
289,997 Total Patients Enrolled
9 Trials studying Prostate Cancer
1,890 Patients Enrolled for Prostate Cancer
Michael Knopp, MDPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have metal clips or staples from surgery in my body.I experience significant anxiety or claustrophobia.I have heart problems or issues with blood circulation and sweating.My kidney function is severely reduced.I have kidney problems related to liver disease or after liver transplant surgery.I have prostate cancer with a Gleason score of 7 or higher and a PSA over 10ng/dl.I will sign a consent form before getting an MRI as per Ohio State University's rules.My kidney function test shows a filtration rate of at least 30 mL/min.My kidney function is low, as shown by a recent test.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (3T MRI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this clinical trial still open?
"Based on the clinicaltrials.gov records, this study is not currently seeking participants to enrol in their trial. Initial postings were made back in September 2007 and the listing has been updated as recently as November 2022; however, 1321 other trials are actively looking for patients right now."
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