Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Phase 1

Completed

• Conditions: Liver Fibrosis; Pulmonary Fibrosis; Myocardial Fibrosis
• Interventions: Drug: 68Ga-FAP-2286; Procedure: Positron Emission Tomography (PET)

• Registration Number: NCT05180162
• Lead Sponsor: Thomas Hope

Brief Summary

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

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 Timeline

• Study Start: 2021-12-09
• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-06
• Primary Completion: 2024-05-28
• Study Completion: 2024-05-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Liver Fibrosis	68Ga-FAP-2286	Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
Cohort 1: Liver Fibrosis	Positron Emission Tomography (PET)	Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
Cohort 2: Pulmonary Fibrosis	68Ga-FAP-2286	Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
Cohort 2: Pulmonary Fibrosis	Positron Emission Tomography (PET)	Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
Cohort 3: Myocardial Fibrosis	Positron Emission Tomography (PET)	Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
Cohort 3: Myocardial Fibrosis	68Ga-FAP-2286	Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with treatment-related adverse events	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.
Median peak standardized uptake value (SUVpeak) in liver region	Up to 1 days	The median SUVpeak in regions of known liver fibrosis will be reported with 95% confidence intervals
Median peak standardized uptake value (SUVpeak) in lung region	Up to 1 days	The median SUVpeak in regions of known pulmonary fibrosis will be reported with 95% confidence intervals
Median peak standardized uptake value (SUV) in myocardium region	Up to 1 days	The median SUVpeak in regions of known myocardial fibrosis will be reported with 95% confidence intervals

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States