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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06353321
Study type Observational
Source University of Texas Southwestern Medical Center
Contact Sarah Neufeld, MS, MBA
Phone 214 648-1836
Email Sarah.Hardee@UTSouthwestern.edu
Status Not yet recruiting
Phase
Start date April 1, 2024
Completion date October 1, 2025

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