Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

NCT05180162 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 20-32872
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Fibrosis; Pulmonary Fibrosis; Myocardial Fibrosis

Keywords

Positron Emission Tomography (PET); Imaging; 68Ga-FAP-2286

Outcome Measures

Primary Outcomes (4)

• Proportion of participants with treatment-related adverse events

  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.

  Up to 31 days

• Median peak standardized uptake value (SUVpeak) in liver region

  The median SUVpeak in regions of known liver fibrosis will be reported with 95% confidence intervals

  Up to 1 days

• Median peak standardized uptake value (SUVpeak) in lung region

  The median SUVpeak in regions of known pulmonary fibrosis will be reported with 95% confidence intervals

  Up to 1 days

• Median peak standardized uptake value (SUV) in myocardium region

  The median SUVpeak in regions of known myocardial fibrosis will be reported with 95% confidence intervals

  Up to 1 days

Study Arms (3)

Cohort 1: Liver Fibrosis

EXPERIMENTAL

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

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

Cohort 2: Pulmonary Fibrosis

EXPERIMENTAL

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

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

Cohort 3: Myocardial Fibrosis

EXPERIMENTAL

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

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

Interventions

68Ga-FAP-2286 DRUG

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

Also known as: 68Gallium-Fibroblast Activation Protein-2286

Cohort 1: Liver Fibrosis; Cohort 2: Pulmonary Fibrosis; Cohort 3: Myocardial Fibrosis

Positron Emission Tomography (PET) PROCEDURE

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

Also known as: PET Imaging, PET Scan

Cohort 1: Liver Fibrosis; Cohort 2: Pulmonary Fibrosis; Cohort 3: Myocardial Fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Hope: lead
• Clovis Oncology, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94122, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis; Pulmonary Fibrosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Thomas A Hope, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: December 9, 2021
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)