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Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1
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
Who can join
All ages · Men
Full eligibility criteria
Inclusion Criteria: * Men with prostate adenocarcinoma undergoing standard of care PSMA-PET imaging for initial staging or re-staging at suspected relapse/progression Exclusion Criteria: * 1\. Known psychiatric or substance abuse disorder which in the opinion of the investigator would interfere with study conduct 2\. Patient weight exceeding 450 lb (weight limit of RefleXion X1 system) 3\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
About the study
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.
What is being tested
- PET-CT imaging subsystem of the RefleXion X1 System Device (diagnostic test)
Sponsor: University of Texas Southwestern Medical Center · Participants: 25 · Started: Dec 12, 2024
Contact the study team
- Sarah Neufeld, MS, MBA · Phone: 214 648-1836
- Cristian Gonzalez · Phone: 214 648-1836
Official record on ClinicalTrials.gov — NCT06353321
Locations in the U.S.
| Texas | Ut Southwestern Medical Center, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.