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

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ClinicalTrials.gov Identifier: NCT05641896
Recruitment Status : Recruiting
First Posted : December 8, 2022
Last Update Posted : May 2, 2024
Sponsor:
Information provided by (Responsible Party):
SOFIE

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancers Cholangiocarcinoma Gastric Cancer Colorectal Cancer Pancreatic Ductal Adenocarcinoma Hepatocellular Carcinoma Drug: [18F]FAPI-74 PET/CT Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
Actual Study Start Date : April 28, 2023
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis. [ Time Frame: Through study completion, 2 years ]
    Lesions positive for FAP as detected by immunohistochemistry and Lesions positive for FAP as detected by [18F]FAPI-74 PET imaging


Secondary Outcome Measures :
  1. Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for histopathology. [ Time Frame: Through study completion, 2 years ]
    Malignant lesions as detected by histopathology and Lesions positive for FAP as detected by [18F]FAPI-74 PET imaging

  2. Further characterize the safety profile of [18F]FAPI-74 in subjects utilizing Common Terminology Criteria for Adverse Events (CTCAE v5) [ Time Frame: Through study completion, 2 years ]
    Incidence and severity of treatment emergent adverse events occurring within 24 hours.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641896


Contacts
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Contact: Sherly Mosessian, Ph.D 818-400-7620 sherly.mosessian@sofie.com
Contact: Bridget Adams 319-430-1192 bridget.adams@sofie.com

Locations
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United States, California
University of California Los Angeles (UCLA) Health Recruiting
Los Angeles, California, United States, 90095
Contact: Aletta Deranteriassian       ADeranteriassian@mednet.ucla.edu   
Principal Investigator: Mark Girgis, M.D.         
Sub-Investigator: Jeremie Calais, M.D., M.Sc         
United States, Massachusetts
Massachusetts general hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Deanna Pucillo    617-726-1312    dmpucillo@mgh.harvard.edu   
Principal Investigator: Shadi Abdar Esfahani, MD, MPH         
United States, Michigan
BAMF Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Clayton McNamara, RN    616-330-2735    Clayton.mcnamara@bamfhealth.com   
Principal Investigator: Harshad Kulkarni, M.D.         
United States, New York
Northwell Health Recruiting
Lake Success, New York, United States, 11042
Contact: Christopher Caravella, MHA    631-449-3133    ccaravella@northwell.edu   
Principal Investigator: Josephine N Rini, M.D.         
Memorial Sloan Kettering Cancer Center (MSKCC) Recruiting
New York, New York, United States, 10065
Contact: Abby Guruparan       gurupara@mskcc.org   
Principal Investigator: Ali-Aria Razmaria, M.D.         
Sponsors and Collaborators
SOFIE
More Information
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Responsible Party: SOFIE
ClinicalTrials.gov Identifier: NCT05641896    
Other Study ID Numbers: 18FFAPI-2023P2
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SOFIE:
Fibroblast Activation Protein
Fibroblast Activation Protein Inhibitor
FAPI
Gastrointestinal Cancer
Additional relevant MeSH terms:
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Cholangiocarcinoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type