Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Last updated: March 19, 2025
Sponsor: Thomas Hope
Overall Status: Completed

Phase

1

Condition

Lung Injury

Cystic Fibrosis

Pulmonary Fibrosis

Treatment

68Ga-FAP-2286

Positron Emission Tomography (PET)

Clinical Study ID

NCT05180162
20-32872
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >= 18 years.

  2. Confirmed pathologic fibrosis in one of the following cohorts

  3. Cohort 1: Hepatic fibrosis, based on cirrhosis on imaging or hepatic fibrosison liver biopsy.

  4. Cohort 2: Pulmonary fibrosis, based on CT findings or biopsy of lungparenchyma.

  5. Cohort 3: High likelihood of cardiac fibrosis as indicated by known cardiacsarcoidosis or amyloidosis (shown on MRI or Fluorodeoxyglucose (FDG) PET),recent myocardial infarction within the last 30 days (as shown by an elevatedtroponin), known cardiotoxicity (decreased ejection fraction on systemictherapy), or other known inflammatory or infiltrative disease.

  6. Ability to understand a written informed consent document, and the willingness tosign it.

Exclusion

Exclusion Criteria:

  1. Unlikely to comply with protocol procedures, restrictions and requirements andjudged by the Investigator to be unsuitable for participation.

  2. Known pregnancy.

Study Design

Total Participants: 16
Treatment Group(s): 2
Primary Treatment: 68Ga-FAP-2286
Phase: 1
Study Start date:
December 09, 2021
Estimated Completion Date:
May 28, 2024

Study 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.

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94122
    United States

    Site Not Available

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