NCT01653093

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	3-Tesla magnetic resonance imaging (3T MRI)	Undergo 3T MRI
PROCEDURE	diffusion-weighted magnetic resonance imaging	Undergo diffusion-weighted MRI
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging	Undergo DCE-MRI
PROCEDURE	magnetic resonance spectroscopic imaging	Undergo MR spectroscopy

Timeline

• Start date: 2007-09-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2012-07-30
• Last updated: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study