Actively Recruiting

MALE
NCT06353321

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

MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Ut Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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