Active — Not RecruitingNot Applicable

3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer

United States280 participantsStarted 2007-09-20

Plain-language summary

In standard clinical care, the prostate is imaged by magnetic resonance imaging (MRI) which is a procedure to take pictures of body structures by using a strong magnetic field and radio waves. The strength of the magnet used is expressed in the unit Tesla (T); a higher Tesla number means the magnet has stronger pull. Standard magnetic resonance imaging of the prostate uses a magnet 1.5 Tesla strong as well as a specialized endorectal coil (antenna) inserted into the body due to the limitations using an external body coil at this magnet strength. MRI using a 3 Tesla magnet has a theoretical advantage over imaging at 1.5 Tesla of creating a signal twice as strong that can be received by the antennas, resulting in better pictures. The goal of this study is to make the MRI procedure more comfortable for patients by using an external coil instead of an endorectal coil. With this study, researchers also want to help patients' health care teams, the surgeons in particular. Researchers will assess the impact of prostate MRI, without an endorectal coil, done at 3 Tesla and with an external body coil on helping doctors decide which approaches to disease therapy might be best for patients as well as correlate patients' study images with all other clinical imaging

Who can participate

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with known or suspected prostate disease based on clinical data will be included in the study; patients with intermediate to high grade prostate cancer (Gleason's score \>= 7 and prostate-specific antigen \[PSA\] of \> 10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians * Written informed consent will be signed by the patients before the MRI based on the guidelines approved by the Ohio State University Institutional Review board * Patients must have an estimated glomerular filtration rate of \>= 30 mL/min/1.73m\^2 within six weeks of the MRI to be included in the study Exclusion Criteria: * Patients with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.) * Patients with any type of ferromagnetic bioimplant that could potentially be displaced or damaged * Patients that have vascular or aneurysm clips, or metallic staples from a surgical procedure * Patients with permanent tattoo eye liner (may contain metallic coloring) * Patients that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims * Patients that exhibit noticeable anxiety and/or claustrophobia * Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 6 years

Trial details

NCT IDNCT01653093

SponsorUniversity of Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Prostate Cancer trials

Plain-language summary

Who can participate

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.