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Completed

NCT Number: NCT05180162

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.

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Key information

Conditions

Liver Fibrosis Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Lung Diseases Lung Diseases, Interstitial Myocardial Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Francisco

San Francisco, California, 94122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-FAP-2286

Drug

A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)

Other names: 68Gallium-Fibroblast Activation Protein-2286

Positron Emission Tomography (PET)

Procedure

Imaging will begin 50-100 minutes after injection and last about 45 minutes.

Other names: PET Imaging, PET Scan

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Thomas Hope

Other

Collaborators

  • Clovis Oncology, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2022
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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