Trial results for a study investigating RefleXion PET/CT imaging in patients with Prostate Cancer were posted on ClinicalTrials.gov on 2025-12-17, with 34 participants enrolled.
Background
Prostate cancer is a common malignancy, and accurate imaging is crucial for diagnosis, staging, and treatment planning. Positron Emission Tomography-Computed Tomography (PET-CT) using tracers like \[18F\]-DCFPyL, which binds to prostate-specific membrane antigen (PSMA) on tumor cells, has become an established method for identifying prostate cancer lesions. The integration of advanced imaging systems, such as the RefleXion Medical Radiotherapy System (RMRS), aims to enhance the precision of both diagnostic visualization and subsequent radiotherapy planning. This trial specifically evaluated the performance of the X1 RMRS imaging system in this context.
Trial design
This study, designated as Phase NA, enrolled 34 participants with Prostate Carcinoma. The trial aimed to examine the performance of the RefleXion Medical Radiotherapy System (RMRS) imaging compared to standard of care \[18F\]-DCFPyL positron emission tomography-computed tomography (PET-CT) imaging. The study evaluated the ability of the X1 RMRS PET-CT system to visualize tumors and generate acceptable biology-guided radiotherapy (BgRT) plans.
Key results
The trial reported two key measurements related to the imaging performance of the X1 RefleXion Medical Radiotherapy System (RMRS) PET-CT:
- The number of participants with tumor visualized on X1 RMRS PET-CT was 1 participant.
- The number of cases where X1 RMRS \[18F\]-DCFPyL PET data could be used to generate an acceptable Biology-guided Radiotherapy (BgRT) plan was 18 participants.
What this means
The posted results provide specific counts regarding the performance of the RefleXion PET/CT imaging system in prostate cancer patients. The data indicates that tumor visualization was achieved in 1 participant, and that the imaging data was suitable for generating an acceptable biology-guided radiotherapy plan in 18 participants. These findings suggest that the X1 RMRS PET-CT system has the potential to contribute to both diagnostic assessment and treatment planning for prostate cancer, particularly in the context of advanced radiotherapy techniques. Further research may explore the broader clinical utility and comparative effectiveness of this imaging approach.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05470699, titled "RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer", were posted on 2025-12-17 on clinicaltrials.gov.