Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC) (FAPI-PRO)

May 29, 2026 updated by: SOFIE

A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET/CT for the Detection of Metastatic Disease in Adults With Pancreatic Ductal Adenocarcinoma

This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo [¹⁸F]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such [¹⁸F]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of [¹⁸F]FAPI-74 PET/CT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Cerritos, California, United States, 90703
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Cancer Center
        • Contact:
        • Principal Investigator:
          • Yufei Liu, M.D, Ph.D
      • Irvine, California, United States, 92618
        • Recruiting
        • Hoag Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Gary Ulaner, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
        • Contact:
        • Principal Investigator:
          • Mark Girgis, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Matteo Novello, MD
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffit Cancer Center
        • Contact:
        • Principal Investigator:
          • Ghassan El-Haddad, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health University Hospital
        • Contact:
        • Principal Investigator:
          • Cindy Yuan, MD PhD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Shadi Esfahani, MD
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass/Shields
        • Contact:
        • Principal Investigator:
          • Elisa Franquet-Elia, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Aria Razmari, MD
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Sampanna Rayamajhi, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Nicholas Austin, DO
      • Kettering, Ohio, United States, 45429
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania, Perelman School of Medicine
        • Contact:
        • Principal Investigator:
          • Mark Sellmyer, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female adults ≥ 18 years.
  • Participants with confirmed PDAC, undergoing staging evaluation for treatment planning.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2:
  • Provided signed, written informed consent obtained prior to any study-related procedures.
  • Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of [¹⁸F]FAPI-74 administration.
  • For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal implants, combined oral contraceptives, vasectomized partner , during the trial intervention period.

Exclusion Criteria:

  • Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.
  • Known hypersensitivity to [¹⁸F]FAPI-74.
  • Administration of another investigational therapeutic or diagnostic product within 30 days prior to [¹⁸F]FAPI-74 administration.
  • Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of [¹⁸F]FAPI-74 administration.
  • Previous cancer diagnosis (except basal cell carcinoma of the skin or in situ carcinoma of the cervix/uterus). Participants treated with curative intent and disease-free for more than 5 years are permitted.
  • Hepatic function: T. bili >1.5X ULN or alk phos, ALT, or AST >5X ULN
  • Renal function: GFR < 30 mL/min
  • Pregnant or breast feeding (a negative pregnancy test is required in women of childbearing potential)
  • Inability to undergo the PET/CT scanning procedure.
  • Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  • Sarcoidosis
  • Treatment, including chemotherapy, radiation or surgery for curative intent of PDAC.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with pancreatic ductal adenocarcinoma receiving [18F]FAPI-74
Drug: [18F]FAPI-74 PET/CT
[18F]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with pancreatic ductal adenocarcinoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
Time Frame: Time Frame: From enrollment to the end of treatment after 3 month follow up
To evaluate the diagnostic performance of [¹⁸F]FAPI-74 PET/CT scan in determining the presence or absence of metastatic disease (M1) in patients with pancreatic ductal adenocarcinoma compared with a composite standard of truth (SOT).
Time Frame: From enrollment to the end of treatment after 3 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events using CTCAE v5.
Time Frame: 24-72 hours post-injection
To assess the safety profile of [¹⁸F]FAPI-74 PET/CT.
24-72 hours post-injection
Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement
Time Frame: From enrollment to the end of treatment after 3 month follow up
To assess inter-and intra-reader variability in image interpretation of the presence of metastatic disease
From enrollment to the end of treatment after 3 month follow up
Number of participants with treatment-related adverse events as assessed by body temperature changes
Time Frame: 24-72 hours post-injection
To assess the safety profile of [¹⁸F]FAPI-74 PET/CT.
24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by blood pressure changes
Time Frame: 24-72 hours post-injection
To assess the safety profile of [¹⁸F]FAPI-74
24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by respiration rate
Time Frame: 24-72 hours post-injection
To assess the safety profile of [¹⁸F]FAPI-74
24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by pulse rate
Time Frame: 24-72 hours post-injection
To assess the safety profile of [¹⁸F]FAPI-74
24-72 hours post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOFIE

Investigators

  • Study Director: Sherly Mosessian, Ph.D, Sofie Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 14, 2025

First Submitted That Met QC Criteria

October 15, 2025

First Posted (Actual)

October 16, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18FFAPI-2025P3-PDAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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