Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286
This is a single arm prospective pilot trial that evaluates the ability of a novel imaging agent (68Ga-FAP-2286) to identify pathologic fibrosis in the setting of hepatic, cardiac and pulmonary fibrosis.
FAP-2286 is a peptide that potently and selectively binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on fibroblasts and has been shown to have higher expression in idiopathic pulmonary fibrosis (IPF), cirrhosis, and cardiac fibrosis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. All cohorts: Safety of 68Ga-FAP-2286.
II. Cohort 1: Measured uptake of radiotracer (SUVpeak) in regions of known liver fibrosis.
III. Cohort 2: Measured uptake of radiotracer (SUVpeak) in regions of known pulmonary fibrosis.
IV. Cohort 3: Measured uptake of radiotracer (SUVpeak) in regions of myocardial fibrosis.
EXPLORATORY OBJECTIVES:
I. Correlation of 68Ga-FAP-2286 uptake with FAP expression determined by immunohistochemistry.
II. Compare 68Ga-FAP-2286 scan results to archival Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET) images.
Patients will receive a single administration of 68Ga-FAP-2286 prior to PET imaging and will be followed for up to two hours after the injection of 68Ga-FAP-2286 for evaluation of adverse events.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94122
- University of California, San Francisco
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >= 18 years.
Confirmed pathologic fibrosis in one of the following cohorts
- Cohort 1: Hepatic fibrosis, based on cirrhosis on imaging or hepatic fibrosis on liver biopsy.
- Cohort 2: Pulmonary fibrosis, based on CT findings or biopsy of lung parenchyma.
- Cohort 3: High likelihood of cardiac fibrosis as indicated by known cardiac sarcoidosis or amyloidosis (shown on MRI or Fluorodeoxyglucose (FDG) PET), recent myocardial infarction within the last 30 days (as shown by an elevated troponin), known cardiotoxicity (decreased ejection fraction on systemic therapy), or other known inflammatory or infiltrative disease.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
- Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- Known pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort 1: Liver Fibrosis
Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
|
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
Other Names:
Imaging will begin 50-100 minutes after injection and last about 45 minutes.
Other Names:
|
|
Experimental: Cohort 2: Pulmonary Fibrosis
Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
|
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
Other Names:
Imaging will begin 50-100 minutes after injection and last about 45 minutes.
Other Names:
|
|
Experimental: Cohort 3: Myocardial Fibrosis
Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
|
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
Other Names:
Imaging will begin 50-100 minutes after injection and last about 45 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants with treatment-related adverse events
Time Frame: Up to 31 days
|
Proportion of participants with Adverse Events, as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 will be reported.
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Up to 31 days
|
|
Median peak standardized uptake value (SUVpeak) in liver region
Time Frame: Up to 1 days
|
The median SUVpeak in regions of known liver fibrosis will be reported with 95% confidence intervals
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Up to 1 days
|
|
Median peak standardized uptake value (SUVpeak) in lung region
Time Frame: Up to 1 days
|
The median SUVpeak in regions of known pulmonary fibrosis will be reported with 95% confidence intervals
|
Up to 1 days
|
|
Median peak standardized uptake value (SUV) in myocardium region
Time Frame: Up to 1 days
|
The median SUVpeak in regions of known myocardial fibrosis will be reported with 95% confidence intervals
|
Up to 1 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas A Hope, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-32872
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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