NCT01653093Active, not recruiting
3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer
Imaging of the Prostate Gland Using High Field Strength 3T MRI
Source: ClinicalTrials.gov · Last updated 11 Apr 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 26 Jul 2012
- Start date
- 20 Sept 2007
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Cincinnati
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT01653093
What you commit to
- Study type: Interventional
- Planned participants: 280
- From 20 Sept 2007 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 that have vascular or aneurysm clips, or metallic staples from a surgical procedure
Other illness
- Patients who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)
- Acute or chronic severe renal insufficiency (estimated glomerular filtration rate \< 30 mL/min/1.73m\^2)
- Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period
Other
- Patients with any type of ferromagnetic bioimplant that could potentially be displaced or damaged
- 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 communicate with the researcher
- Patients with an estimated glomerular filtration rate of \< 30 mL/min/1.73m\^2 within six weeks of the MRI
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University Medical Center, Stress Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.