Evaluating imaging performance of a new PET-CT system for prostate cancer
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
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 type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Sex | Male |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06353321 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men with prostate adenocarcinoma undergoing standard PSMA-PET imaging for initial staging or re-staging.
Not a fit: Patients with psychiatric disorders, excessive weight, or uncontrolled illnesses may not benefit from this study.
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 performed: While this approach is innovative, similar studies have shown promise in enhancing imaging techniques for cancer diagnostics.
Eligibility criteria
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 this trial is running
Dallas, Texas
- Ut Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Neil Desai, MD — University of Texas Southwestern Medical Center
- Study coordinator: Sarah Neufeld, MS, MBA
- Email: Sarah.Hardee@UTSouthwestern.edu
- Phone: 214 648-1836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.