Clinical trial · Observational
Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1
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
NCT06353321CI-TRIAL-00100686recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET-CT imaging subsystem of the RefleXion X1 System Device | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single group non blinded
- description
- Single Center Study, pilot/feasibility, private for profit observational study
- interventionNames
- Diagnostic Test: PET-CT imaging subsystem of the RefleXion X1 System Device
Primary outcomes (1)
- measure
- Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT
- timeFrame
- From time of Reflexion scan to 48 hours after scan for adverse event evaluation
- description
- Qualitative imaging performance of the PET subsystem on the X1 system for detect PSMA-11 68Ga (Illuccix)-avid lesions (primary and metastatic) in patients with prostate cancer, relative to diagnostic \[68Ga\]-PSMA-11 PET-CT. This will be assessed by the enrolling investigator with the following question: Is there an Illuccix (PSMA-11 Ga68) avid target that correlates to the tumor location on the registered CT image? (Yes/No)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Men with prostate adenocarcinoma undergoing standard of care PSMA-PET imaging for initial staging or re-staging at suspected relapse/progression Exclusion Criteria: * 1\. Known psychiatric or substance abuse disorder which in the opinion of the investigator would interfere with study conduct 2\. Patient weight exceeding 450 lb (weight limit of RefleXion X1 system) 3\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.