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

Primary Purpose

Gastrointestinal Cancers, Cholangiocarcinoma, Gastric Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
[18F]FAPI-74 PET/CT
Sponsored by
SOFIE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastrointestinal Cancers focused on measuring Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor, FAPI, Gastrointestinal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts general hospitalRecruiting
  • BAMF HealthRecruiting
  • Memorial Sloan Kettering Cancer Center (MSKCC)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]FAPI-74 PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.
Lesions positive for FAP as detected by immunohistochemistry and Lesions positive for FAP as detected by [18F]FAPI-74 PET imaging

Secondary Outcome Measures

Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for histopathology.
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)
Incidence and severity of treatment emergent adverse events occurring within 24 hours.

Full Information

First Posted
November 29, 2022
Last Updated
October 18, 2023
Sponsor
SOFIE
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1. Study Identification

Unique Protocol Identification Number
NCT05641896
Brief Title
Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
Acronym
18F-FAPI-74 GI
Official Title
A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOFIE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancers, Cholangiocarcinoma, Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Hepatocellular Carcinoma
Keywords
Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor, FAPI, Gastrointestinal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[18F]FAPI-74 PET/CT
Arm Type
Experimental
Arm Description
Patients receive [18F]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later
Intervention Type
Drug
Intervention Name(s)
[18F]FAPI-74 PET/CT
Intervention Description
[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.
Primary Outcome Measure Information:
Title
Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.
Description
Lesions positive for FAP as detected by immunohistochemistry and Lesions positive for FAP as detected by [18F]FAPI-74 PET imaging
Time Frame
Through study completion, 2 years
Secondary Outcome Measure Information:
Title
Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for histopathology.
Description
Malignant lesions as detected by histopathology and Lesions positive for FAP as detected by [18F]FAPI-74 PET imaging
Time Frame
Through study completion, 2 years
Title
Further characterize the safety profile of [18F]FAPI-74 in subjects utilizing Common Terminology Criteria for Adverse Events (CTCAE v5)
Description
Incidence and severity of treatment emergent adverse events occurring within 24 hours.
Time Frame
Through study completion, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherly Mosessian, Ph.D
Phone
818-400-7620
Email
sherly.mosessian@sofie.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bridget Adams
Phone
319-430-1192
Email
bridget.adams@sofie.com
Facility Information:
Facility Name
Massachusetts general hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Deffler
Phone
617-643-9481
Email
CDEFFLER@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Shadi Abdar Esfahani, MD, MPH
Facility Name
BAMF Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton McNamara, RN
Phone
616-330-2735
Email
Clayton.mcnamara@bamfhealth.com
First Name & Middle Initial & Last Name & Degree
Harshad Kulkarni, M.D.
Facility Name
Memorial Sloan Kettering Cancer Center (MSKCC)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abby Guruparan
Email
gurupara@mskcc.org
First Name & Middle Initial & Last Name & Degree
Ali-Aria Razmaria, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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