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Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Primary Purpose

Liver Fibrosis, Pulmonary Fibrosis, Myocardial Fibrosis

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

68Ga-FAP-2286

Positron Emission Tomography (PET)

About this trial

This is an interventional diagnostic trial for Liver Fibrosis focused on measuring Positron Emission Tomography (PET), Imaging, 68Ga-FAP-2286

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age >= 18 years.
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.
Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
Known pregnancy.

Sites / Locations

University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1: Liver Fibrosis

Cohort 2: Pulmonary Fibrosis

Cohort 3: Myocardial Fibrosis

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05180162

First Posted

December 17, 2021

Last Updated

January 5, 2023

Sponsor

Thomas Hope

Collaborators

Clovis Oncology, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05180162

Brief Title

Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Official Title

Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 9, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Thomas Hope

Collaborators

Clovis Oncology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Fibrosis, Pulmonary Fibrosis, Myocardial Fibrosis

Keywords

Positron Emission Tomography (PET), Imaging, 68Ga-FAP-2286

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: Liver Fibrosis

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2: Pulmonary Fibrosis

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 3: Myocardial Fibrosis

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

68Ga-FAP-2286

Other Intervention Name(s)

68Gallium-Fibroblast Activation Protein-2286

Intervention Description

A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography (PET)

Other Intervention Name(s)

PET Imaging, PET Scan

Intervention Description

Imaging will begin 50-100 minutes after injection and last about 45 minutes.

Primary Outcome Measure Information:

Title

Proportion of participants with treatment-related adverse events

Description

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.

Time Frame

Up to 31 days

Title

Median peak standardized uptake value (SUVpeak) in liver region

Description

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

Time Frame

Up to 1 days

Title

Median peak standardized uptake value (SUVpeak) in lung region

Description

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

Time Frame

Up to 1 days

Title

Median peak standardized uptake value (SUV) in myocardium region

Description

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

Time Frame

Up to 1 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >= 18 years. Confirmed pathologic fibrosis in one of the following cohorts Cohort 1: Hepatic fibrosis, based on cirrhosis on imaging or hepatic fibrosis on liver biopsy. Cohort 2: Pulmonary fibrosis, based on CT findings or biopsy of lung parenchyma. 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. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation. Known pregnancy.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brad Kline

Phone

877-827-3222

Brad.Kline@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas A Hope, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94122

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brad Kline

Phone

877-827-3222

Brad.Kline@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Thomas A Hope, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

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