Recruiting
Phase 2

FAPI PET/MRI

Sponsor:

University of Wisconsin, Madison

Code:

NCT06675357

Conditions

Prostate Cancer Metastatic Disease

Prostate Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FAPI

Positron Emission Tomography (PET)

Magnetic Resonance Imaging

Study Details

Brief 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.

Conditions

Prostate Cancer Metastatic Disease

Prostate Cancers

Study ID

NCT06675357

Start date

Feb 27, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or older
  • Able and willing to provide informed consent
  • Known diagnosis of prostate cancer
  • Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET
  • Optional: 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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Fibroblast activation protein inhibitor (FAPI)

FAPI radiotracer will be used during PET

Interventions

FAPI

5 +/- 2 mCi of Ga-FAPI-46

Positron Emission Tomography (PET)

Undergo PET scan

Magnetic Resonance Imaging

Undergo MRI scan

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Radiology Studies

608-282-8349Radstudy@uwhealth.org

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Principal Investigator:

Ali Pirasteh, MD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-06-10.