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Imaging of the Prostate Gland Using High Field Strength 3T MRI


N/A
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Imaging of the Prostate Gland Using High Field Strength 3T MRI


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil

Outcome Time Frame:

Up to 6 years

Safety Issue:

No

Principal Investigator

Michael Knopp, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-07042

NCT ID:

NCT01653093

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

The Ohio State University Medical Center, StressColumbus, Ohio  43210