Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607783
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
PRostate Cancer Enhanced Diagnosis by Calibration Technology
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-Centre Pivotal Stage Study to Determine the Between MRI Scanner Reproducibility of Gold Standard Phantom Calibrated Acquisition Replicator CARE for Measurement of Apparent Diffusion Coefficients in the Prostate of Patients with MR Positive Lesions Destined for Biopsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
PREDICT
Brief Summary:
The CARE Phantom system is a medical device system that is being developed has been designed to enable the quantitative measurement of the apparent diffusion coefficient ADC in the prostate of patients undergoing a multi-parametric MRI mpMRI scan to detect prostate cancer The final device system will comprise three elements a calibration mat containing phantoms and embedded monitoring software a docking station to transfer data from the phantoms and software as a medical device SaMD for calibrating the resulting mpMRI images
In this clinical trial patients will undergo MRI scanning in different scanners using the GSP Phantoms to provide mpMRI images and phantom data for subsequent in silico analysis The captured images and data will be used to further develop and calibrate the GSP prototype SaMD part of the medical device system and to establish the degree of optimised reproducibility that can be achieved
In this clinical trial patients will undergo MRI scanning in different scanners using the GSP Phantoms to provide mpMRI images and phantom data for subsequent in silico analysis The captured images and data will be used to further develop and calibrate the GSP prototype SaMD part of the medical device system and to establish the degree of optimised reproducibility that can be achieved
Detailed Description:
None
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