Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1
Recruiting · NCT06353321 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
PET-CT imaging subsystem of the RefleXion X1 System Device
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.
Who can take part
Age range
No age limits stated
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
- \. Patient weight exceeding 450 lb (weight limit of RefleXion X1 system)
- \. 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.
Where it is running
1 location listed across 1 US state.
- Ut Southwestern Medical Center - Dallas, Texas, United States