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Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1

NCT06353321 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • RefleXion Medical

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Neil Desai, MD · University of Texas Southwestern Medical Center

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2026-12-12
Completion
2026-12-14
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353321 on ClinicalTrials.gov