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Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Sponsor
Thomas Hope (Other)
Overall Status
Recruiting
CT.gov ID
NCT05180162
Collaborator
Clovis Oncology, Inc. (Industry)
30
Enrollment
1
Location
3
Arms
12.7
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

PRIMARY OBJECTIVES:

  1. All cohorts: Safety of 68Ga-FAP-2286.

  2. Cohort 1: Measured uptake of radiotracer (SUVpeak) in regions of known liver fibrosis.

  3. Cohort 2: Measured uptake of radiotracer (SUVpeak) in regions of known pulmonary fibrosis.

  4. Cohort 3: Measured uptake of radiotracer (SUVpeak) in regions of myocardial fibrosis.

EXPLORATORY OBJECTIVES:

  1. Correlation of 68Ga-FAP-2286 uptake with FAP expression determined by immunohistochemistry.

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286
Actual Study Start Date :
Dec 9, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: Liver Fibrosis

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

Drug: 68Ga-FAP-2286
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
Other Names:
  • 68Gallium-Fibroblast Activation Protein-2286

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

    		•
    Experimental: Cohort 2: Pulmonary Fibrosis

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

    Drug: 68Ga-FAP-2286
    A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
    Other Names:
  • 68Gallium-Fibroblast Activation Protein-2286

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

    		•
    Experimental: Cohort 3: Myocardial Fibrosis

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

    Drug: 68Ga-FAP-2286
    A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
    Other Names:
  • 68Gallium-Fibroblast Activation Protein-2286

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants with treatment-related adverse events [Up to 31 days]

      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.

    2. Median peak standardized uptake value (SUVpeak) in liver region [Up to 1 days]

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

    3. Median peak standardized uptake value (SUVpeak) in lung region [Up to 1 days]

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

    4. Median peak standardized uptake value (SUV) in myocardium region [Up to 1 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age >= 18 years.

    2. Confirmed pathologic fibrosis in one of the following cohorts

    3. Cohort 1: Hepatic fibrosis, based on cirrhosis on imaging or hepatic fibrosis on liver biopsy.

    4. Cohort 2: Pulmonary fibrosis, based on CT findings or biopsy of lung parenchyma.

    5. 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.

    6. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94122

    Sponsors and Collaborators

    • Thomas Hope
    • Clovis Oncology, Inc.

    Investigators

    • Principal Investigator: Thomas A Hope, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Hope, Principal Investigator, University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT05180162
    Other Study ID Numbers:
    • 20-32872
    First Posted:
    Jan 6, 2022
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Thomas Hope, Principal Investigator, University of California, San Francisco
    Positron Emission Tomography (PET)
    Imaging
    68Ga-FAP-2286
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Pulmonary Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Jan 6, 2022