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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks how well the RefleXion X1 system makes PET-CT images using Illuccix, a drug that helps show prostate cancer on scans. It is for men with prostate cancer who are having a routine PSMA-PET-CT scan on the same day.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men with prostate adenocarcinoma, a type of prostate cancer.
  • Having a routine PSMA-PET scan to see how far the cancer has spread, or to check if it may have returned or gotten worse.

Who can't join

  • A known mental health or substance use disorder that the study doctor thinks would interfere with the study.
  • Weight over 450 pounds, the system’s weight limit.
  • An illness that is not under control, or personal circumstances, that the study doctor thinks would make it hard to follow study requirements. Examples include an active infection, heart failure with symptoms, unstable chest pain, an irregular heartbeat, or mental illness.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

TX