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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: PET-CT imaging subsystem of the RefleXion X1 System Device

• Registration Number: NCT06353321
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Study Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-09
• Study Start: 2024-12-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-12-12
• Study Completion: 2025-12-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group non blinded	PET-CT imaging subsystem of the RefleXion X1 System Device	Single Center Study, pilot/feasibility, private for profit observational study

Primary Outcome Measures

Name	Time	Method
Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT	From time of Reflexion scan to 48 hours after scan for adverse event evaluation	Qualitative imaging performance of the PET subsystem on the X1 system for detect PSMA-11 68Ga (Illuccix)-avid lesions (primary and metastatic) in patients with prostate cancer, relative to diagnostic \[68Ga\]-PSMA-11 PET-CT.; This will be assessed by the enrolling investigator with the following question: Is there an Illuccix (PSMA-11 Ga68) avid target that correlates to the tumor location on the registered CT image? (Yes/No)

Trial Locations

Locations (1)

Ut Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States