Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Apr 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique using a special device called the RefleXion X1 System to help doctors see prostate cancer more clearly. The trial will focus on men who are undergoing standard imaging tests for prostate cancer, either when they are first diagnosed or when doctors suspect the cancer has returned. The goal is to understand how well this new imaging method works compared to the usual tests done on the same day.

To be eligible for this study, participants need to be men diagnosed with prostate adenocarcinoma who are scheduled for a PSMA-PET scan. However, there are some important criteria that could exclude someone from joining. For example, if a man has a significant psychiatric disorder, weighs over 450 pounds, or has certain uncontrolled health issues, he may not be able to participate. If someone joins the trial, they can expect to undergo imaging tests that could provide more accurate information about their cancer, which might help in their treatment planning.

Gender

MALE

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.