Clinical trial Recruiting at 1 site Observational Men only

Evaluating imaging performance of a new PET-CT system for prostate cancer

Official title: 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

Run by University of Texas Southwestern Medical Center · NCT06353321 · Data updated 2026-11-12

This study is testing a new PET-CT imaging system to see if it works better than traditional scanners for men with prostate cancer.

Quick facts

Study typeObservational
SexMen only
Enrollment25 (estimated)
SponsorUniversity of Texas Southwestern Medical Center
Academic / other
Drugs / interventionsradiation
Locations1 site (Dallas, Texas)
StatusRecruiting
StartedDecember 12, 2024
Main results expectedDecember 12, 2026
Study endsDecember 14, 2026
Registry record updatedJanuary 12, 2026
Trial IDNCT06353321 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with prostate adenocarcinoma undergoing standard PSMA-PET imaging for initial staging or re-staging.

Probably not a fit

Patients with psychiatric disorders, excessive weight, or uncontrolled illnesses may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to qualitatively assess the imaging performance of the PET-CT subsystem of the RefleXion X1 System in men with prostate cancer. Participants will undergo standard-of-care PSMA-11 PET-CT imaging using Illuccix, followed by imaging on the X1 platform on the same day. The study focuses on comparing the imaging capabilities of the X1 system to traditional diagnostic imaging scanners, providing insights into its effectiveness in various clinical scenarios. The findings will enhance the understanding of PSMA-11-guided BioGuide Radiotherapy (BgRT) delivery in prostate cancer treatment.

Why it matters

Potential benefit: If successful, this study could improve imaging techniques for prostate cancer, leading to better diagnosis and treatment planning.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in enhancing imaging techniques for cancer diagnostics.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Ut Southwestern Medical Center
    Dallas, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.