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

University of Texas Southwestern Medical Center25 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Interventions

PET-CT imaging subsystem of the RefleXion X1 System DeviceDIAGNOSTIC_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

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (1)

Ut Southwestern Medical Center

Dallas, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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)

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

Central Contacts

Sarah Neufeld, MS, MBA

CONTACT

214 648-1836 Sarah.Hardee@UTSouthwestern.edu

Cristian Gonzalez

CONTACT

214 648-1836 Cristian.Gonzalez@UTSouthwestern.edu

Data from ClinicalTrials.gov

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