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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

Tracking Information
First Submitted Date  ICMJE November 29, 2022
First Posted Date  ICMJE December 8, 2022
Last Update Posted Date May 2, 2024
Actual Study Start Date  ICMJE April 28, 2023
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2022)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2022)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
Official Title  ICMJE A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Gastrointestinal Cancers
  • Cholangiocarcinoma
  • Gastric Cancer
  • Colorectal Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Hepatocellular Carcinoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: [18F]FAPI-74 PET/CT
Patients receive [18F]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later
Intervention: Drug: [18F]FAPI-74 PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2022)		 120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2025
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherly Mosessian, Ph.D 818-400-7620 sherly.mosessian@sofie.com
Contact: Bridget Adams 319-430-1192 bridget.adams@sofie.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05641896
Other Study ID Numbers  ICMJE 18FFAPI-2023P2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party SOFIE
Original Responsible Party Same as current
Current Study Sponsor  ICMJE SOFIE
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SOFIE
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP