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Spots Global Cancer Trial Database for Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach

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Trial Identification

Brief Title: Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach

Official Title: Prostate Cancer Localization With a Multiparametric MR Approach

Study ID: NCT01138527

Conditions

Prostate Cancer

Interventions

MRI examination

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Tom W Scheenen, PhD

Affiliation: Radiology, Radboud University Nijmegen Medical Centre

Role: PRINCIPAL_INVESTIGATOR

Name: Jurgen J Fütterer, MD PhD

Affiliation: Radiology, Radboud University Nijmegen Medical Centre

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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