Recruiting

[68Ga]-PSMA-11

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06353321

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

PET-CT imaging subsystem of the RefleXion X1 System Device

Study Details

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

Study ID

NCT06353321

Start date

Dec 12, 2024

Status verified date

Jan, 2026

Completion date

Dec 14, 2026

Anticipated

Primary completion date

Dec 12, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Single group non blinded

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

Interventions

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

Primary outcome measure

  • Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT [ Time Frame: From time of Reflexion scan to 48 hours after scan for adverse event evaluation ]

Central Contacts and Locations

Central contacts

Sarah Neufeld, MS, MBA

214 648-1836Sarah.Hardee@UTSouthwestern.edu

Cristian Gonzalez

214 648-1836Cristian.Gonzalez@UTSouthwestern.edu

Locations

Ut Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

SARAH NEUFELD

214-648-1836SARAH.HARDEE@UTSOUTHWESTERN.EDU

LILIANA ROBLES

214 648 1836LILIANA.ROBLES@UTSOUTHWESTERN.EDU

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-01-12.