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

The University of Texas System (UT)

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Diagnostic Test: PET-CT imaging subsystem of the RefleXion X1 System Device

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06353321

STU-2024-0024

Details and patient eligibility

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.

Full 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.

Enrollment

25 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

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.