- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05641896
Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers (18F-FAPI-74 GI)
December 7, 2023 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
120
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 Contact
- Name: Sherly Mosessian, Ph.D
- Phone Number: 818-400-7620
- Email: sherly.mosessian@sofie.com
Study Contact Backup
- Name: Bridget Adams
- Phone Number: 319-430-1192
- Email: bridget.adams@sofie.com
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Caitlin Deffler
- Phone Number: 617-643-9481
- Email: CDEFFLER@mgh.harvard.edu
-
Principal Investigator:
- Shadi Abdar Esfahani, MD, MPH
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- BAMF Health
-
Contact:
- Clayton McNamara, RN
- Phone Number: 616-330-2735
- Email: Clayton.mcnamara@bamfhealth.com
-
Principal Investigator:
- Harshad Kulkarni, M.D.
-
-
New York
-
Lake Success, New York, United States, 11042
- Recruiting
- Northwell Health
-
Contact:
- Christopher Caravella, MHA
- Phone Number: 631-449-3133
- Email: ccaravella@northwell.edu
-
Principal Investigator:
- Josephine N Rini, M.D.
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center (MSKCC)
-
Contact:
- Abby Guruparan
- Email: gurupara@mskcc.org
-
Principal Investigator:
- Ali-Aria Razmaria, M.D.
-
-
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
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
|
[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 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
|
Through study completion, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Through study completion, 2 years
|
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.
|
Through study completion, 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
July 31, 2024
Study Completion (Estimated)
March 31, 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 (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
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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