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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3-Tesla magnetic resonance imaging (3T MRI)
diffusion-weighted magnetic resonance imaging
dynamic contrast-enhanced magnetic resonance imaging
magnetic resonance spectroscopic imaging
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Medical Center, Stress

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (3T MRI)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2012
Last Updated
February 24, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01653093
Brief Title
3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer
Official Title
Imaging of the Prostate Gland Using High Field Strength 3T MRI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2007 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (3T MRI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
3-Tesla magnetic resonance imaging (3T MRI)
Other Intervention Name(s)
3-Tesla MRI, 3T MRI
Intervention Description
Undergo 3T MRI
Intervention Type
Procedure
Intervention Name(s)
diffusion-weighted magnetic resonance imaging
Other Intervention Name(s)
diffusion-weighted MRI
Intervention Description
Undergo diffusion-weighted MRI
Intervention Type
Procedure
Intervention Name(s)
dynamic contrast-enhanced magnetic resonance imaging
Other Intervention Name(s)
DCE-MRI
Intervention Description
Undergo DCE-MRI
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance spectroscopic imaging
Other Intervention Name(s)
1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging
Intervention Description
Undergo MR spectroscopy
Primary Outcome Measure Information:
Title
Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil
Description
The primary outcome in this study is the agreement in tumor staging between pathology and 3 Tesla MRI.
Time Frame
Up to 6 years

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Knopp, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center, Stress
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
Jamesline

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

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