We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT05180162
Previous Study | Return to List | Next Study

Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05180162
Recruitment Status : Recruiting
First Posted : January 6, 2022
Last Update Posted : January 9, 2023
Sponsor:
Collaborator:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Liver Fibrosis Pulmonary Fibrosis Myocardial Fibrosis Drug: 68Ga-FAP-2286 Procedure: Positron Emission Tomography (PET) Phase 1

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 9, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 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 Name: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of participants with treatment-related adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 1 days ]
    The median SUVpeak in regions of known myocardial fibrosis will be reported with 95% confidence intervals


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05180162


Contacts
Layout table for location contacts
Contact: Brad Kline 877-827-3222 Brad.Kline@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94122
Contact: Brad Kline    877-827-3222    Brad.Kline@ucsf.edu   
Principal Investigator: Thomas A Hope, MD         
Sponsors and Collaborators
Thomas Hope
Clovis Oncology, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Thomas A Hope, MD University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Thomas Hope, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05180162    
Other Study ID Numbers: 20-32872
First Posted: January 6, 2022    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Hope, University of California, San Francisco:
Positron Emission Tomography (PET)
Imaging
68Ga-FAP-2286
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Liver Diseases
Digestive System Diseases