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

NCT06353321 | Recruiting DMC FDA Drug FDA Device

• 1 other identifier: STU-2024-0024
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT

  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)

  From time of Reflexion scan to 48 hours after scan for adverse event evaluation

Study Arms (1)

Single group non blinded

Single Center Study, pilot/feasibility, private for profit observational study

Diagnostic Test: PET-CT imaging subsystem of the RefleXion X1 System Device

Interventions

PET-CT imaging subsystem of the RefleXion X1 System Device DIAGNOSTIC_TEST

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

Single group non blinded

Eligibility Criteria

• Gender Eligibility Details: Males with prostate adenocarcinoma undergoing standard of care PSMA-PET imaging
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Men with prostate adenocarcinoma undergoing standard of care PSMA-PET imaging for initial staging or re-staging at suspected relapse/progression

You may not qualify if:

• \. Known psychiatric or substance abuse disorder which in the opinion of the investigator would interfere with study conduct
• \. Patient weight exceeding 450 lb (weight limit of RefleXion X1 system)
• \. 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• RefleXion Medical: collaborator

Study Sites (1)

Ut Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Neil Desai, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Neufeld, MS, MBA

CONTACT

214 648-1836; Sarah.Hardee@UTSouthwestern.edu

Cristian Gonzalez

CONTACT

214 648-1836; Cristian.Gonzalez@UTSouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 9, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)