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

Clinicaltrials.gov ID: NCT06580015
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 21 Years
b-bullseye-arrow Enrollments 20

Conditions

Prostate Carcinoma

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the imaging performance of flotufolastat F-18 gallium ([18F]-rhPSMA) PET-CT imaging subsystem of the RefleXion Medical Radiotherapy System Device in patients with lesions detected on standard-of-care (SOC) [18F]-rhPSMA PET-CT on the same day.

SECONDARY OBJECTIVES:

I. To evaluate the frequency that SOC Posluma imaging will result in the ability to distinctly identify and separate PET activity from bladder activity to aid in the detection, lesion contouring, RT planning and RT delivery for intra-prostatic lesions, prostate bed lesions (salvage RT) or lesions near the bladder.

II. To evaluate the frequency that SOC Posluma imaging will result in a change in radiotherapy planning through either exclusion due to extra-pelvic metastatic disease or detection of disease that results in a modification of RT field coverage or dose.

III. Evaluate the potential for using the X1 RMRS PET used to generate an acceptable BgRT plan such that dosimetric parameters for the target and the nearby normal anatomy are met based on investigator assessment.

OUTLINE:

Patients receive SOC flotufolastat F-18 gallium intravenously (IV) and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.

After completion of study intervention, patients are followed up within 72 hours of PET imaging-only session.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Jeffrey Y Wong, MD

Eligibility Criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Study Plan

Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)

EXPERIMENTAL

Patients receive SOC flotufolastat F-18 gallium IV and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.

  • PROCEDURE:

    Computed Tomography

    Description:

    Undergo PET-CT

  • OTHER:

    Flotufolastat F-18 Gallium

    Description:

    Given IV

  • OTHER:

    Medical Device Usage and Evaluation

    Description:

    Undergo X1 RMRS PET-CT

  • PROCEDURE:

    Positron Emission Tomography

    Description:

    Undergo PET-CT

Outcome Measures

Primary Outcome Measures

Comparison of imaging performance of the [18F]-rhPSMA positron emission tomography (PET)-computed tomography (CT) on the X1 RefleXion Medical Radiotherapy System (RMRS)

Time Frame: Up to 72 hours after completion of imagining session

Secondary Outcome Measures

Incidence of change in treatment planning based on SOC Posluma

Time Frame: Up to 72 hours after imaging session

Percent of cases where X1 RMRS PET data can be used to generate an acceptable biology-guided radiotherapy (BgRT) plan

Time Frame: Up to 72 hours after imaging session

Timeline

  • Last Updated
    March 11, 2025
  • Start Date
    August 30, 2024
  • Today
    May 11, 2025
  • Completion Date ( Estimated )
    January 9, 2027

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