Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Thomas Hope

Status and phase: Completed; Phase 1

Conditions: Pulmonary Fibrosis; Myocardial Fibrosis; Liver Fibrosis

Treatments: Procedure: Positron Emission Tomography (PET); Drug: 68Ga-FAP-2286

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05180162

20-32872

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >= 18 years.

2. Confirmed pathologic fibrosis in one of the following cohorts

   1. Cohort 1: Hepatic fibrosis, based on cirrhosis on imaging or hepatic fibrosis on liver biopsy.
   2. Cohort 2: Pulmonary fibrosis, based on CT findings or biopsy of lung parenchyma.
   3. 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.

3. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
2. Known pregnancy.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 3 patient groups

Cohort 1: Liver Fibrosis

Experimental group

Description:

Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.

Treatment:

Drug: 68Ga-FAP-2286

Procedure: Positron Emission Tomography (PET)

Cohort 2: Pulmonary Fibrosis

Experimental group

Description:

Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.

Treatment:

Drug: 68Ga-FAP-2286

Procedure: Positron Emission Tomography (PET)

Cohort 3: Myocardial Fibrosis

Experimental group

Description:

Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.

Treatment:

Drug: 68Ga-FAP-2286

Procedure: Positron Emission Tomography (PET)