RecruitingNot ApplicableNCT06580015

[18F]-rhPSMA PET-CT Imaging Performance in Patients With Prostate Cancer

Posluma (18F-rhPSMA) PET Guided Radiotherapy Planning in Prostate Cancer: A Prospective Study Evaluating POSLUMA PET Tumor Detection on Radiation Therapy Planning and on BGRT Planning on the RefleXion X1 System


Sponsor

City of Hope Medical Center

Enrollment

20 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial evaluates \[18F\]-rh PSMA positron emission tomography (PET)-computed tomography (CT) imaging performance in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA. Because some cancers take up \[18F\]-rhPSMA, cancer cells can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Posluma (18F-rhPSMA) is an approved prostate-specific membrane antigen (PSMA) imaging agent for prostate cancer. The RefleXion Medical Radiotherapy System (RMRS) is designed to facilitate delivery of biology-guided radiotherapy (BgRT). The system uses PET emissions to guide radiotherapy delivery in real-time and has been studied for use with fludeoxyglucose (FDG) (which is an agent used in standard PET-CT scans that targets glucose). Information gathered from this study may help researchers to improve PET-CT imaging on the RefleXion system. This information will be used in the future to improve planning and delivery of radiation therapy that will target (in real time) the signal released from the \[18F\]-rhPSMA PET-CT tracer. Comparing the imaging from the standard of care \[18F\]-rh PSMA PET-CT with the imaging from RMRS may help improve the quality of the imaging captured on the RMRS for detection of imaging signals in patients with prostate cancer.


Eligibility

Sex: MALEMin Age: 21 Years

Inclusion Criteria4

  • Documented informed consent of the participant and/or legally authorized representative
  • Age: ≥ 21 years
  • Patients with SOC \[18F\]-RhPSMA PET-CT in whom a PET avid lesion is identified
  • Able to get same day X1 RMRS PET

Exclusion Criteria2

  • Known psychiatric or substance abuse disorder that would interfere with conduct of the study
  • Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet

Interventions

PROCEDUREComputed Tomography

Undergo PET-CT

OTHERFlotufolastat F-18 Gallium

Given IV

OTHERMedical Device Usage and Evaluation

Undergo X1 RMRS PET-CT

PROCEDUREPositron Emission Tomography

Undergo PET-CT


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06580015


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