Contrast Enhanced MRI of the Prostate

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Advanced Imaging Research Center, OHSU

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Prostate Cancer Detection and Aggressiveness Monitoring by Contrast Enhanced MRI

Time frame: within 60 days after MRI data collection

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Sep 19, 2014
Registry last updated: Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed