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: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:
• Men with prostate adenocarcinoma undergoing standard of care PSMA-PET imaging for initial staging or re-staging at suspected relapse/progression
Locations
United States
Texas
Ut Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Sarah Neufeld, MS, MBA
Sarah.Hardee@UTSouthwestern.edu
214 648-1836
Backup
Cristian Gonzalez
Cristian.Gonzalez@UTSouthwestern.edu
214 648-1836
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2025-12-14
Participants
Target number of participants: 25
Treatments
Single group non blinded
Single Center Study, pilot/feasibility, private for profit observational study
Related Therapeutic Areas
Sponsors
Collaborators: RefleXion Medical
Leads: University of Texas Southwestern Medical Center