Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Thomas A Hope, MD
Headshot of Thomas A Hope
Thomas A Hope

Description

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.

Details

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.

Keywords

Liver Fibrosis, Pulmonary Fibrosis, Myocardial Fibrosis, Positron Emission Tomography (PET), Imaging, 68Ga-FAP-2286, Liver Cirrhosis, Fibrosis

Eligibility

You can join if…

Open to people ages 18 years and up

  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 fibrosis on liver biopsy.
  4. Cohort 2: Pulmonary fibrosis, based on CT findings or biopsy of lung parenchyma.
  5. 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.
  6. Ability to understand a written informed consent document, and the willingness to sign it.

You CAN'T join if...

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

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94122 United States

Lead Scientist at UCSF

  • Thomas A Hope, MD
    Thomas Hope, MD, is the Vice Chair of Clinical Operations and Strategy in the Department of Radiology. He also serves as the Director of Molecular Therapy. He serves as Chief of Nuclear Medicine at the San Francisco VA Medical Center and as chair of the Cancer Center’s Molecular Imaging & Radionuclide Therapy Site Committee.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Thomas Hope
ID
NCT05180162
Phase
Phase 1 Fibrosis Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated