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
2 other identifiers
interventional
280
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Sep 2007
Longer than P75 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2007
CompletedFirst Submitted
Initial submission to the registry
July 26, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 11, 2025
April 1, 2025
19.3 years
July 26, 2012
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil
The primary outcome in this study is the agreement in tumor staging between pathology and 3 Tesla MRI.
Up to 6 years
Study Arms (1)
Diagnostic (3T MRI)
EXPERIMENTALPatients 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.
Interventions
Undergo 3T MRI
Undergo diffusion-weighted MRI
Undergo DCE-MRI
Undergo MR spectroscopy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 communicate with the researcher
- Patients who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)
- Patients with an estimated glomerular filtration rate of \< 30 mL/min/1.73m\^2 within six weeks of the MRI
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University Medical Center, Stress
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Knopp, MD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 26, 2012
First Posted
July 30, 2012
Study Start
September 20, 2007
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 11, 2025
Record last verified: 2025-04