Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1
Status
RECRUITING
Phase
Age
All Ages
Enrollments
25Conditions
Prostate CancerSummary
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.
Detailed Description
In this non-significant risk (NSR) study, investigators will perform imaging only (no treatment) on the X1 platform immediately following an already planned PET/CT diagnostic imaging using Illuccix for standard of care indications in men with prostate cancer of various stages. This approach will be used to assess imaging performance of the X1 in comparison to diagnostic imaging scanners. Evidence from this study will supplement and enhance technical understanding of the PSMA-11-guided BgRT delivery in the setting of prostate cancer. As such, the patient population selected for this investigation is meant to optimally represent the spectrum of cases, with respect to motion and radiographic environment that a radiation oncologist may encounter in practice.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- SARAH NEUFELD
- 214-648-1836
- [email protected]
Principal Investigator
- Neil Desai, MD
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.
Study Plan
Single group non blinded
Single Center Study, pilot/feasibility, private for profit observational study
DIAGNOSTIC_TEST:
PET-CT imaging subsystem of the RefleXion X1 System DeviceDescription:
Imaging performed only on the X1 platform immediately following already planned imaging using Illuccix for standard of care indications in men with prostate cancer of various stages, in order to assess performance of the X1 in comparison to diagnostic imaging scanners
Outcome Measures
Primary Outcome Measures
Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT
Timeline
Last Updated
February 25, 2025Start Date
April 9, 2024Today
May 12, 2025Completion Date ( Estimated )
December 14, 2025
Sponsors of this trial
Lead Sponsor
University of Texas Southwestern Medical CenterCollaborating Sponsors
RefleXion Medical
RECRUITING 
≥ 18 Years