Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers (18F-FAPI-74 GI)

September 9, 2026 updated by: SOFIE

A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles (UCLA) Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts general hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • BAMF Health
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Rochester
    • New York
      • Lake Success, New York, United States, 11042
        • Northwell Health
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (MSKCC)

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of gastrointestinal (GI) malignancy, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer
  • Available tissue sample obtained through biopsy or to be obtained through scheduled biopsy and/or surgical resection
  • No treatment received between tissue sample taken and [18F]FAPI-74 PET
  • Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
  • Age ≥ 18 years
  • Completed informed consent as determined per the IRB of record

Exclusion Criteria:

  • Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
  • Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
  • Need for emergent surgery that would be delayed by participation
  • Bacterial, viral, or fungal infections requiring systemic therapy, that are expected to impact FAP expression in the opinion of the sponsor or their designee
  • Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise subject safety and/or protocol objectives
  • Known diagnosis of an autoimmune disorder that is expected to impact FAP expression in the opinion of the sponsor or their designee
  • Patients receiving any other investigational agent within the past 28 days
  • Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [18F]FAPI-74 injection
  • Known hypersensitivity to any excipients used in [18F]FAPI-74: trace amounts of sodium acetate, sodium ascorbate, ascorbic acid, ethanol, acetonitrile or AlCl.
  • Renal or liver function impairment* *Defined by liver impairments as AST>3x the upper limit of normal, ALT>3x the upper limit of normal, or bilirubin>1.5x the upper limit of normal. Renal impairment as defined by a creatinine clearance of >1.5x the upper limit of normal utilizing the Cockcroft Gault formula

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: [18F]FAPI-74 PET/CT

Patients receive [18F]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later
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 gastrointestinal cancers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Predictive Value (PPV) of [18F]FAPI-74 PET Imaging Using Immunohistochemistry (IHC)
Time Frame: Day 1

The positive or negative status according to [18F]FAPI-74 PET imaging was determined based on a prespecified cut-off value for each appropriate test as determined by the clinician. Positivity was evaluated using the following prespecified H-score thresholds: > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only. The primary efficacy endpoint was the positive predictive value of [18F]FAPI-74 PET imaging, defined as the proportion of PET-positive results that were confirmed positive by IHC. PPV was summarized using proportions along with two-sided 95% asymptotic normal confidence intervals.
Day 1
Sensitivity of [18F]FAPI-74 PET Imaging to Detect FAP-Expressing Cells, Using IHC
Time Frame: Day 1

Sensitivity was defined as the proportion of participants with IHC confirmed FAP-expressing cells who had a positive [18F]FAPI-74 PET result for the primary lesion. Sensitivity was calculated as A / (A + C), where A represents true positive findings and C represents false negative findings. Higher sensitivity indicates a greater ability of [18F]FAPI-74 PET to detect IHC confirmed FAP expression and a lower likelihood of false negative results, thereby reflecting the effectiveness of the imaging modality relative to the IHC reference standard. Sensitivity was presented overall for all IHC-positive results and separately using stricter IHC cut-off values categorized as: > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only.
Day 1
Specificity of [18F]FAPI-74 PET Imaging to Detect Absence of FAP-Expressing Cells, Using IHC as Truth Standard
Time Frame: Day 1

Specificity was defined as the proportion of participants without IHC-confirmed FAP-expressing cells who had a negative [18F]FAPI-74 PET result for the primary lesion. Specificity was calculated by comparing positive and negative [18F]FAPI-74 PET findings with the corresponding IHC results, using a single readable PET image matched to its reference IHC assessment. Specificity was calculated as D / (B + D), where B represents false-positive findings and D represents true-negative findings. PET results were compared with the corresponding IHC reference assessment using a single readable PET image per participant. Specificity was evaluated overall using IHC negativity defined as > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPV of [18F]FAPI-74 PET Images to Detect Cancer Cells Using Histopathology as Truth Standard
Time Frame: Day 1

Positive Predictive Value (PPV) of [18F]FAPI-74 PET imaging in detecting presence of disease using histopathology as the truth standard. The PPV is defined as the probability that one is indeed positive for an outcome given that they test positive for the outcome and is calculated as: PPV = A/(A + B), where A represents true-positive findings and B represents false-positive findings (PET positive but histopathology negative). PPV was summarized using proportions along with two-sided 95% asymptotic normal confidence intervals.
Day 1
Sensitivity of [18F]FAPI-74 PET Imaging to Detect Cancers Cells, Using Histopathology as Truth Standard
Time Frame: Day 1

Sensitivity was defined as the proportion of participants with histopathology-confirmed cancers cells who had a positive [18F]FAPI-74 PET result for the primary lesion. Sensitivity was calculated by comparing positive and negative [18F]FAPI-74 PET findings with the corresponding histopathology results, using a single readable PET image matched to its reference histopathology assessment. Sensitivity was calculated as A / (A + C), where A represents true-positive findings and C represents false-negative findings. Sensitivity was summarized using proportions along with two-sided 95% asymptotic normal confidence intervals.
Day 1
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Time Frame: From study intervention administration (Day 1) to 72 hours post-injection

An adverse event (AE) is any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention.

A TEAE is defined as any untoward medical occurrence that begins or worsens in intensity or frequency after the initiation of a treatment (e.g., drug, device, or procedure) in a clinical study.

A serious TEAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization.
From study intervention administration (Day 1) to 72 hours post-injection

Collaborators and Investigators

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

Sponsor

SOFIE

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)

April 28, 2023

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

November 29, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

October 1, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18FFAPI-2023P2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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