Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Conditions
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Liver Fibrosis, Pulmonary Fibrosis, Myocardial Fibrosis

Intervention / Treatment
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* Drug: 68Ga-FAP-2286
* Procedure: Positron Emission Tomography (PET)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Liver Fibrosis<br>Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. | Drug: 68Ga-FAP-2286<br>* A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)<br>* Other names: 68Gallium-Fibroblast Activation Protein-2286;Procedure: Positron Emission Tomography (PET)<br>* Imaging will begin 50-100 minutes after injection and last about 45 minutes.<br>* Other names: PET Scan;|
| Experimental: Cohort 2: Pulmonary Fibrosis<br>Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. | Drug: 68Ga-FAP-2286<br>* A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)<br>* Other names: 68Gallium-Fibroblast Activation Protein-2286;Procedure: Positron Emission Tomography (PET)<br>* Imaging will begin 50-100 minutes after injection and last about 45 minutes.<br>* Other names: PET Scan;|
| Experimental: Cohort 3: Myocardial Fibrosis<br>Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. | Drug: 68Ga-FAP-2286<br>* A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)<br>* Other names: 68Gallium-Fibroblast Activation Protein-2286;Procedure: Positron Emission Tomography (PET)<br>* Imaging will begin 50-100 minutes after injection and last about 45 minutes.<br>* Other names: PET Scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with treatment-related adverse events | 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. | Up to 31 days | 
| Median peak standardized uptake value (SUVpeak) in liver region | The median SUVpeak in regions of known liver fibrosis will be reported with 95% confidence intervals | Up to 1 days | 
| Median peak standardized uptake value (SUVpeak) in lung region | 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 | The median SUVpeak in regions of known myocardial fibrosis will be reported with 95% confidence intervals | Up to 1 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron Emission Tomography (PET), Imaging, 68Ga-FAP-2286