Clinical trial NCT05180162: Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286
Official title: Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Fibrosis
Pulmonary Fibrosis
Myocardial Fibrosis
Keywords: Positron Emission Tomography (PET)
Imaging
68Ga-FAP-2286
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Clovis Oncology, Inc.
First posted: 2022-01-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with treatment-related adverse events
timeFrame: Up to 31 days
measure: Median peak standardized uptake value (SUVpeak) in liver region
timeFrame: Up to 1 days
measure: Median peak standardized uptake value (SUVpeak) in lung region
timeFrame: Up to 1 days
measure: Median peak standardized uptake value (SUV) in myocardium region
timeFrame: Up to 1 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas A Hope, MD
role: PRINCIPAL_INVESTIGATOR
References: