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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Ohio State University Comprehensive Cancer Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Michael Knopp, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01653093
First received: July 26, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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


Condition Intervention
Prostate Cancer
Procedure: 3-Tesla magnetic resonance imaging
Procedure: diffusion-weighted magnetic resonance imaging
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Imaging of the Prostate Gland Using High Field Strength 3T MRI

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: September 2007
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (3T MRI)
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.
Procedure: 3-Tesla magnetic resonance imaging
Undergo 3T MRI
Other Names:
  • 3-Tesla MRI
  • 3T MRI
Procedure: diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Other Name: diffusion-weighted MRI
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI
Other Name: DCE-MRI
Procedure: magnetic resonance spectroscopic imaging
Undergo MR spectroscopy
Other Names:
  • 1H-nuclear magnetic resonance spectroscopic imaging
  • Proton Magnetic Resonance Spectroscopic Imaging

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the impact of prostate MRI, without an endorectal coil, done at 3-Tesla on surgical management. This would be performed by examining the agreement of lesion location based on the MRI compared to the lesion location based on pathology and/or surgery and local extent of the disease, i.e. involvement of contiguous organs and local lymph nodes, based on the MRI compared to the local extent based on pathology and/or surgery.

II. To test the reproducibility of functional MRI (dynamic-contrast enhanced [DCE_MRI] MRI, magnetic resonance [MR] spectroscopy and diffusion-weighted MRI).

SECONDARY OBJECTIVES:

I. To assess the usefulness of MRI data in treatment planning for radiation therapy, and to test the feasibility of amide-proton-transfer MRI in prostate cancer detection.

II. To evaluate MRI changes in prostate and tumor morphology between endorectal coil versus no endorectal coil.

III. To assess the usefulness of ex-vivo prostate specimen MRI for accurate co-registration between in-vivo MRI of the prostate and pathology slides.

OUTLINE:

Patients undergo 3-tesla (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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653093

Contacts
Contact: The Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Michael Knopp, MD 614-293-9998 knopp.16@osu.edu

Locations
United States, Ohio
The Ohio State University Medical Center, Stress Recruiting
Columbus, Ohio, United States, 43210
Contact: Michael V. Knopp    614-293-9998    knopp.16@osu.edu   
Principal Investigator: Michael V. Knopp         
Sponsors and Collaborators
Michael Knopp
Investigators
Principal Investigator: Michael Knopp, MD Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Knopp, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01653093     History of Changes
Other Study ID Numbers: OSU-07042, NCI-2012-00931
Study First Received: July 26, 2012
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 25, 2014