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RECRUITING
NCT06353321

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

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

25

Start Date

2024-12-12

Completion Date

2026-12-14

Last Updated

2026-01-12

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

PET-CT imaging subsystem of the RefleXion X1 System Device

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

Locations (1)

Ut Southwestern Medical Center

Dallas, Texas, United States