Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579417
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
ART-Pro Clinical Trial Evaluating Biparametric MRI and Advanced Quantitative Diffusion MRI for Detection of Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Advanced Restriction Imaging and Reconstruction Technology for Prostate MRI ART-Pro
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ART-Pro
Brief Summary:
This is a multicenter multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer csPCa The study will enroll 500 participants at 5 clinical centers 100 participants per center The current standard MRI technique for prostate cancer screening is multiparametric MRI mpMRI but two drawbacks include need for intravenous IV contrast and dependence on radiologist expertise The investigators expect that the combination of two other techniques biparametric MRI bpMRI and Restriction Spectrum Imaging restriction score RSIrs will help non-expert radiologists achieve similar performance to expert radiologists using bpMRI or mpMRI for detection of csPCa while avoiding the drawbacks that are present when using mpMRI
Detailed Description:
ART-Pro will be conducted in two phases ART-Pro-1 and ART-Pro-2 and will evaluate bpMRI mpMRI and RSIrs an advanced quantitative diffusion technique for detection of csPCa ART-Pro-1 will evaluate these techniques prospectively by having each patients MRI exam read by 2 expert radiologists both using different subsets of the images to evaluate the different techniques ART-Pro-1 will additionally evaluate RSIrs as a stand-alone quantitative biomarker ART-Pro-2 will evaluate these same techniques retrospectively using radiologists of varying experience levels novice basic and expert and findings will be evaluated against the expertly created dataset from ART-Pro-1 Patients will be followed after initial enrollment for the purpose of extracting relevant medical outcomes such as biopsy results or surgery pathology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None