Clinical trial · Interventional
RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer
A Prospective Study of the RefleXion [18F]- DCFPyL PET-CT Subsystem Imaging Performance in Patients With Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial examines RefleXion Medical Radiotherapy System (RMRS) imaging to the standard of care (SOC) \[18F\]-DCFPyL positron emission tomography-computed tomography (PET-CT) imaging in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of a tracer, \[18F\]-DCFPyL, that binds to prostate specific membrane antigen (PSMA) on tumor cells. These PSMA tumor cells can then be identified on PET imaging. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. The RMRS is a imaging-therapy combination system that can plan for and deliver radiation therapy as well perform \[18F\]-DCFPyL PET-CT imaging. Comparing the imaging from the standard of care \[18F\]-DCFPyL-PET-CT with the \[18F\]-DCFPyL imaging from RMRS may help improve the quality of the imaging captured and determine if imaging can be done on the RMRS at the same time as planning for radiation therapy, which would reduce the number of scans needed to plan for radiation for prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Fluorine F 18 Piflufolastat | Other | — | UNRESOLVED |
| Positron Emission Tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT)
- description
- Patients receive \[18F\]-DCFPyL IV and undergo \[18F\]-DCFPyL PET-CT over 30 minutes per SOC. Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.
- interventionNames
- Procedure: Computed Tomography
- Other: Fluorine F 18 Piflufolastat
- Device: Positron Emission Tomography
Primary outcomes (1)
- measure
- Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT)
- timeFrame
- Up to 72 hours after completion of scan
- description
- To determine imaging performance of the X1 PET scan, the number of tumors clearly visualized on PET scan were reported.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Age \>= 21 years * Patients undergoing SOC \[18F\]-DCFPyL PET-CT * Patients should be scheduled for \[18F\]-DCFPyL PET-CT prior to study entry Exclusion Criteria: * Known psychiatric or substance abuse disorder that would interfere with conduct of the study * Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet
References
Publications (0)
Data not yet available