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| Name | Class |
|---|---|
| Clovis Oncology, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Liver Fibrosis | Experimental | Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. |
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| Cohort 2: Pulmonary Fibrosis | Experimental | Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. |
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| Cohort 3: Myocardial Fibrosis | Experimental | Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAP-2286 | Drug | A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Age >= 18 years.
Confirmed pathologic fibrosis in one of the following cohorts
Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A Hope, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94122 | United States |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Positron Emission Tomography (PET) | Procedure | Imaging will begin 50-100 minutes after injection and last about 45 minutes. |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |