A Prospective First-In-Human Pilot Study F-DCFPyL Prostate-Specific Membrane Antigen Imaging on the RefleXion X1 Positron Emission Tomography-Computed Tomograpghy Subsystem in Patients with Prostate Cancer.
[PURPOSE] The RefleXion X1 Medical Radiotherapy System (RefleXion Medical) is a novel radiation therapy (RT) device capable of delivering real-time positron emission tomography (PET) scan-guided or bi
APA
Liu B, Dandapani S, et al. (2025). A Prospective First-In-Human Pilot Study F-DCFPyL Prostate-Specific Membrane Antigen Imaging on the RefleXion X1 Positron Emission Tomography-Computed Tomograpghy Subsystem in Patients with Prostate Cancer.. Advances in radiation oncology, 10(12), 101902. https://doi.org/10.1016/j.adro.2025.101902
MLA
Liu B, et al.. "A Prospective First-In-Human Pilot Study F-DCFPyL Prostate-Specific Membrane Antigen Imaging on the RefleXion X1 Positron Emission Tomography-Computed Tomograpghy Subsystem in Patients with Prostate Cancer.." Advances in radiation oncology, vol. 10, no. 12, 2025, pp. 101902.
PMID
41211608
Abstract
[PURPOSE] The RefleXion X1 Medical Radiotherapy System (RefleXion Medical) is a novel radiation therapy (RT) device capable of delivering real-time positron emission tomography (PET) scan-guided or biology-guided RT (BgRT). The purpose of this pilot study was to evaluate the performance of its PET imaging subsystem to detect 2-(3-{1-carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (F-DCFPyl) prostate-specific membrane antigen [PSMA] PET scan signal as the foundation for BgRT in patients with prostate cancer.
[METHODS AND MATERIALS] Patients underwent a standard diagnostic F-DCFPyl PSMA PET scan. If at least 1 PET-scan-avid tumor was identified, the patient was then scanned on the RefleXion X1 unit. The target volume, activity concentration, and normalized target signal were determined, and BgRT planning was performed.
[RESULTS] In 20 patients, at least 1 PSMA PET-scan-avid tumor was identified for BgRT planning (5 lymph node metastases, 7 bone metastases, 7 prostate glands, and 1 prostate bed). In 18 patients, the PET-scan-avid tumor was visualized on the RefleXion X1 PET scan, whereas in 2 patients, the tumor was too close to the PET scan activity in the bladder to be clearly visualized. BgRT planning was feasible and met stereotactic body RT organ dose constraints in 8 (40%) patients (3 prostate glands, 3 bones, and 2 lymph nodes). BgRT was not feasible in 12 (60%) patients because of low target activity concentration (<5 kBq/mL), low normalized target signal intensity (<2.7), or proximity of the PET-scan-avid tumor to the bladder.
[CONCLUSIONS] This is the first study to demonstrate the feasibility of using F-DCFPyl scan imaging for BgRT planning on the RefleXion X1 system in patients with prostate cancer. BgRT using targeted PET scan radiopharmaceuticals to guide RT represents a promising new dimension in radiation oncology and warrants further investigation.
[METHODS AND MATERIALS] Patients underwent a standard diagnostic F-DCFPyl PSMA PET scan. If at least 1 PET-scan-avid tumor was identified, the patient was then scanned on the RefleXion X1 unit. The target volume, activity concentration, and normalized target signal were determined, and BgRT planning was performed.
[RESULTS] In 20 patients, at least 1 PSMA PET-scan-avid tumor was identified for BgRT planning (5 lymph node metastases, 7 bone metastases, 7 prostate glands, and 1 prostate bed). In 18 patients, the PET-scan-avid tumor was visualized on the RefleXion X1 PET scan, whereas in 2 patients, the tumor was too close to the PET scan activity in the bladder to be clearly visualized. BgRT planning was feasible and met stereotactic body RT organ dose constraints in 8 (40%) patients (3 prostate glands, 3 bones, and 2 lymph nodes). BgRT was not feasible in 12 (60%) patients because of low target activity concentration (<5 kBq/mL), low normalized target signal intensity (<2.7), or proximity of the PET-scan-avid tumor to the bladder.
[CONCLUSIONS] This is the first study to demonstrate the feasibility of using F-DCFPyl scan imaging for BgRT planning on the RefleXion X1 system in patients with prostate cancer. BgRT using targeted PET scan radiopharmaceuticals to guide RT represents a promising new dimension in radiation oncology and warrants further investigation.
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