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Contrast Enhanced MRI of the Prostate

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ClinicalTrials.gov Identifier: NCT02245282
Recruitment Status : Recruiting
First Posted : September 19, 2014
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mark Garzotto, OHSU Knight Cancer Institute

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.

Condition or disease
Prostatic Neoplasms

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast Enhanced MRI of the Prostate
Study Start Date : November 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. Prostate Cancer Detection and Aggressiveness Monitoring by Contrast Enhanced MRI [ Time Frame: within 60 days after MRI data collection ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245282


Contacts
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Contact: Xin Li, Ph. D. 503-418-1533 lxin@ohsu.edu
Contact: William Woodward 503-418-1526 woodwawi@ohsu.edu

Locations
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United States, Oregon
Advanced Imaging Research Center, OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Xin Li, PhD    503-418-1533    lxin@ohsu.edu   
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Xin Li OHSU Knight Cancer Institute

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Responsible Party: Mark Garzotto, Professor, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT02245282    
Other Study ID Numbers: IRB00010345
1R44CA180425 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared to Imbio LLC
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases