Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353321
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-26
Brief Title:
Non-significant Risk NSR Study of 68Ga-PSMA-11 Illuccix as a BgRT BioGuide on RefleXion X1
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Non-significant Risk NSR Study of 68Ga-PSMA-11 Illuccix as a BgRT BioGuide on the RefleXion X1 System in Patients Already Undergoing Diagnostic PET Positron Emission Tomography PSMA Prostate Specific Membrane Antigen Imaging
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
To qualitatively determine the imaging performance of PET-CT imaging subsystem of the RefleXion X1 System Device in patients undergoing standard-of-care SOC 68Ga-PSMA-11 PET-CT using Illuccix on the same day
Detailed Description:
In this non-significant risk NSR study investigators will perform imaging only no treatment on the X1 platform immediately following an already planned PETCT diagnostic imaging using Illuccix for standard of care indications in men with prostate cancer of various stages This approach will be used to assess imaging performance of the X1 in comparison to diagnostic imaging scanners Evidence from this study will supplement and enhance technical understanding of the PSMA-11-guided BgRT delivery in the setting of prostate cancer As such the patient population selected for this investigation is meant to optimally represent the spectrum of cases with respect to motion and radiographic environment that a radiation oncologist may encounter in practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None