Actively Recruiting
Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1
Led by University of Texas Southwestern Medical Center · Updated on 2026-01-12
25
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
R
RefleXion Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men with prostate adenocarcinoma undergoing standard of care PSMA-PET imaging for initial staging or re-staging at suspected relapse or progression
You will not qualify if you...
- Known psychiatric or substance abuse disorder that would interfere with study conduct
- Patient weight exceeding 450 lb (weight limit of RefleXion X1 system)
- Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ut Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
S
Sarah Neufeld, MS, MBA
CONTACT
C
Cristian Gonzalez
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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