Contrast Enhanced MRI of the Prostate

NCT02245282 | Completed DMC

• 2 other identifiers: IRB000103451R44CA180425
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Prostate Cancer Detection and Aggressiveness Monitoring by Contrast Enhanced MRI

  within 60 days after MRI data collection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 20 subjects will be studied under this protocol. Subjects will be selected from patients scheduled for prostate biopsies with known prostate lesions. Subjects will also be recruited from prostate cancer patients who choose radical prostatectomy as disease management plan. The research project will be introduced to a potential subject by a urologist at OHSU. If interested, the subject will then be contacted through phone to participate in the study by an investigator or a research assistant on the research team.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Advanced Imaging Research Center, OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark Garzotto, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 19, 2014
• Study Start: February 10, 2017
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)