Trials / Recruiting
RecruitingNCT06353321
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (estimated)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | PET-CT imaging subsystem of the RefleXion X1 System Device | Imaging performed only on the X1 platform immediately following already planned imaging using Illuccix for standard of care indications in men with prostate cancer of various stages, in order to assess performance of the X1 in comparison to diagnostic imaging scanners |
Timeline
- Start date
- 2024-12-12
- Primary completion
- 2026-12-12
- Completion
- 2026-12-14
- First posted
- 2024-04-09
- Last updated
- 2026-01-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06353321. Inclusion in this directory is not an endorsement.