Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2021-12-09
2024-05-28
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort 1: Liver Fibrosis
Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
68Ga-FAP-2286
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
Positron Emission Tomography (PET)
Imaging will begin 50-100 minutes after injection and last about 45 minutes.
Cohort 2: Pulmonary Fibrosis
Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
68Ga-FAP-2286
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
Positron Emission Tomography (PET)
Imaging will begin 50-100 minutes after injection and last about 45 minutes.
Cohort 3: Myocardial Fibrosis
Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
68Ga-FAP-2286
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
Positron Emission Tomography (PET)
Imaging will begin 50-100 minutes after injection and last about 45 minutes.
Interventions
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68Ga-FAP-2286
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
Positron Emission Tomography (PET)
Imaging will begin 50-100 minutes after injection and last about 45 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Known pregnancy.
18 Years
ALL
No
Sponsors
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Thomas Hope
OTHER
Clovis Oncology, Inc.
INDUSTRY
Responsible Party
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Thomas Hope
Principal Investigator
Principal Investigators
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Thomas A Hope, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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20-32872
Identifier Type: -
Identifier Source: org_study_id
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