Using FAPI PET/MRI to Evaluate Prostate Cancer

Clinicaltrials.gov ID: NCT06675357
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 30

Conditions

Prostate Cancer Metastatic Disease, Prostate Cancers

Summary

The goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer.Participants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Ali Pirasteh, MD

Eligibility Criteria

Inclusion Criteria:

* Age 18 years or older
* Able and willing to provide informed consent
* Known diagnosis of prostate cancer with established or suspected non-osseous, non-nodal metastases
* Scheduled for standard-of-care PSMA PET
* Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases
* Willing and able to undergo PET/MRI as part of this research

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Contraindication(s) to or inability to undergo PET/MRI
* Participants for whom PET/MRI will delay timely delivery of treatment
* Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
* Have their own prescription for the medication
* The informed consent process is conducted prior to the self-administration of this medication
* Come to the research visit with a driver

Study Plan

Fibroblast activation protein inhibitor (FAPI)

EXPERIMENTAL

FAPI radiotracer will be used during PET

  • RADIATION:

    FAPI

    Description:

    5 +/- 2 mCi of Ga-FAPI-46
  • PROCEDURE:

    Positron Emission Tomography (PET)

    Description:

    Undergo PET scan
  • PROCEDURE:

    Magnetic Resonance Imaging

    Description:

    Undergo MRI scan

Outcome Measures

Primary Outcome Measures

Performance of FAPI for lesion detection

Time Frame: Duration of scan, up to 80 minutes

Lesion FAPI uptake on PET

Time Frame: Duration of scan, up to 80 minutes

Total FAPI-positive tumor volume change

Time Frame: Duration of scan, up to 80 minutes

Timeline

  • Last Updated
    November 21, 2024
  • Start Date
    November 5, 2024
  • Today
    January 23, 2025
  • Completion Date ( Estimated )
    October 1, 2026

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