Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01653093
Eligibility Criteria:
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 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
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT01653093
Study Brief:
Protocol Section:
NCT01653093