Contrast Enhanced MRI of the Prostate

Prostatic Neoplasms Clinical Trial

Official title:

Contrast Enhanced MRI of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245282
• Other study ID #: IRB00010345
• Secondary ID: 1R44CA180425
• Status: Completed
• Start date: February 10, 2017
• Est. completion date: December 12, 2018

Study information

• Verified date: September 2020
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prostate cancer detection and disease progression monitoring relies on systematic multi-core biopsies. Minimal invasive imaging capacities for lesion targeting and monitoring are badly needed. The purpose of this study is to determine if a new MRI technique can identify and monitor prostate disease progression. If so biopsy core number can be reduced to as small as one, and frequency for biopsy repeat can be reduced. The new technique is about a new way of analyzing the pictures taken as part of prostate MRI exam. This part is called dynamic contrast-enhanced MRI. It involves an injection of contrast reagent (or dye) through the arm vein during a time period when prostate MRI pictures are continuously taken.

Description:

The aim of the study is to perform contrast-enhanced (CE) magnetic resonance imaging (MRI) at OHSU on subjects with diagnosed prostate cancer. This pilot project will study 20 subjects prior to their next scheduled clinical procedures (biopsy or radical prostatectomy). Data from this project will be used to explore new capabilities of the software platform developed under current SBIR funding. CE-MRI will involve the use of an extracellular (Gadolinium based, Gd) contrast agent. When Gd is used, (dynamic-contrast-enhanced) DCE-MRI signal intensity time-course data will be analyzed analytically using the so called "shutter-speed" paradigm which takes into account of the effects of finite water exchange kinetics. Region of interest (ROI) and high resolution (~millimeter) parametric maps of pathophysiologic quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular volume fraction, will be generated from the DCE-MRI data. All parameters will be compared to literature results for software validation and correlated with pathology for clinical potential.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men, age >18 years.

• Any patient scheduled for prostate biopsy repeat or radical prostatectomy.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients who would be normally excluded from undergoing an MRI examination - patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.

• Patients who are unable to cooperate for an MRI exam.

• Major surgery within a month of enrollment.

• Prostate biopsy six weeks prior to enrollment.

• Subject-reported reaction to gadolinium contrast reagent.

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Advanced Imaging Research Center, OHSU	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate Cancer Detection and Aggressiveness Monitoring by Contrast Enhanced MRI		within 60 days after MRI data collection