Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05882253
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-05-19
Brief Title:
Prostate Cancer IMAGing IN Early Detection IMAGINED Trial
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Validation Calibration and Translation of Restriction Spectrum Imaging Signal Maps to Enhance MRI Diagnostic Capabilities in Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAGINED
Brief Summary:
The researchers hope to learn if specific types of MRI software and techniques can help improve early prostate cancer detection at time of a MRI-guided prostate biopsy
Detailed Description:
A phase 2 prospective interventional non-randomized clinical trial design to investigate whether Restricted Spectrum Maps RSM attained from RSI-MRI On-Q Prostate improves PI-RADS accuracy compared to PI-RADS alone for the detection of clinically significant prostate cancer Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial
The aims of the study are as follows
Goal 1 Validate RSI-MRI imaging biomarker performance using a prospective clinical trial
Goal 2 Calibrate the RSM values across different MRI scanner manufacturers Goal 3 Translate RSI using a net clinical benefit model
The aims of the study are as follows
Goal 1 Validate RSI-MRI imaging biomarker performance using a prospective clinical trial
Goal 2 Calibrate the RSM values across different MRI scanner manufacturers Goal 3 Translate RSI using a net clinical benefit model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA279667 | NIH | None | httpsreporternihgovquickSearchR01CA279667 |