Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Pulmonary Fibrosis Clinical Trial

Official title:

Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180162
• Other study ID #: 20-32872
• Status: Recruiting
• Phase: Phase 1
• Start date: December 9, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Brad Kline
• Phone: 877-827-3222
• Email: Brad.Kline[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis
• Myocardial Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• 68Ga-FAP-2286
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)

Procedure:
• Positron Emission Tomography (PET)
Imaging will begin 50-100 minutes after injection and last about 45 minutes.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Hope	Clovis Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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