Loading clinical trials...
Loading clinical trials...
Prostate Cancer Localization With a Multiparametric MR Approach
The primary objective of this prospective multi-centre study is to prove the diagnostic accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate tissue. The gold standard for distinguishing the tissue types is the analysis of whole-mount sections of the resected prostate by a genitourinary histopathologist.
Goal Proving that multi-parametric MR imaging in a multi-centre setting allows for localizing clinically significant (volume \> 0.5cc; Gleason \> 6) prostate carcinoma in the prostate. Objective 1 To determine the diagnostic accuracy (area under the receiver-operating characteristic curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR imaging in localizing prostate cancer, by correlating: 1. focal areas of low signal intensity on T2-weighted images; 2. the extent and degree of deviating metabolite ratios derived from MRSI. This can be the choline+creatine/citrate ratio or if possible, the choline / citrate ratio; 3. the extent and degree of apparent diffusion coefficient reduction on DWI; 4. the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence of cancer at (reconstructed) whole mount section histopathology. Objective 2 Proving that multi-modality MR data allows for predicting tumor grade. The parameters from the different MR methods for a tumor focus can be correlated to the local Gleason grade of the corresponding lesion in the histopathological specimens.
Age
All ages
Sex
MALE
Healthy Volunteers
No
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States
Medical University Vienna
Vienna, Austria
Ghent University Hospita
Ghent, Belgium
University Health Network, Princess Margaret Hospital
Toronto, Canada
University Medical Center Mannheim, Heidelberg University
Mannheim, Germany
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Norwegian University of Science and Technology
Trondheim, Norway
Mount Vernon Hospital, Paul Strickland Scanner Centre
London, United Kingdom
Start Date
June 1, 2010
Primary Completion Date
August 1, 2015
Completion Date
July 1, 2019
Last Updated
May 13, 2021
148
ACTUAL participants
MRI examination
OTHER
Lead Sponsor
Radboud University Medical Center
Collaborators
NCT06842498
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05691465