Liver FibrosisPhase 1NCT05180162
Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286
A Phase 1 study testing 68Ga-FAP-2286 and Positron Emission Tomography (PET) in people with Liver Fibrosis and Pulmonary Fibrosis, run by Thomas Hope at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis, Pulmonary Fibrosis, Myocardial Fibrosis
- What is being tested?
- 68Ga-FAP-2286 and Positron Emission Tomography (PET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 28 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- Known pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94122
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Liver Fibrosis, Pulmonary Fibrosis, Myocardial Fibrosis
- Being tested
- 68Ga-FAP-2286, Positron Emission Tomography (PET)
- Keywords
- Positron Emission Tomography (PET), Imaging, 68Ga-FAP-2286
- Medical subject headings
- Liver Cirrhosis, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAP-2286Drug
Also called 68Gallium-Fibroblast Activation Protein-2286
A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV)
Positron Emission Tomography (PET)Procedure or surgery
Also called PET Imaging, PET Scan
Imaging will begin 50-100 minutes after injection and last about 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Liver Fibrosis | Experimental | Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. Receives: Drug: 68Ga-FAP-2286; Procedure: Positron Emission Tomography (PET) |
| Cohort 2: Pulmonary Fibrosis | Experimental | Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. Receives: Drug: 68Ga-FAP-2286; Procedure: Positron Emission Tomography (PET) |
| Cohort 3: Myocardial Fibrosis | Experimental | Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. Receives: Drug: 68Ga-FAP-2286; Procedure: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start9 Dec 2021
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Hope
- Sponsor type
- University, hospital or other
- Collaborators
- Clovis Oncology, Inc.
- Responsible party
- Sponsor-investigator, Thomas Hope, University of California, San Francisco
- Investigators
- Thomas A Hope, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180162
- Sponsor's protocol ID
- 20-32872
- Status last verified
- Mar 2025
- First submitted
- 17 Dec 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286
- ClinicalTrials.gov ID
- NCT05180162
- Acronym / sponsor ID
- 20-32872
- Conditions
- Liver Fibrosis, Pulmonary Fibrosis, Myocardial Fibrosis
- Keywords
- Positron Emission Tomography (PET), Imaging, 68Ga-FAP-2286
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Thomas HopeUniversity, hospital or other
- Collaborators
- Clovis Oncology, Inc.
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Liver Fibrosis | Experimental | Drug: 68Ga-FAP-2286, Procedure: Positron Emission Tomography (PET)Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. |
| Cohort 2: Pulmonary Fibrosis | Experimental | Drug: 68Ga-FAP-2286, Procedure: Positron Emission Tomography (PET)Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. |
| Cohort 3: Myocardial Fibrosis | Experimental | Drug: 68Ga-FAP-2286, Procedure: Positron Emission Tomography (PET)Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- Known pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAP-2286Also: 68Gallium-Fibroblast Activation Protein-2286A dose of 3 - 8 millicurie (mCi) will be given intravenously (IV) | Drug | Cohort 1: Liver Fibrosis, Cohort 2: Pulmonary Fibrosis, Cohort 3: Myocardial Fibrosis |
| Positron Emission Tomography (PET)Also: PET Imaging, PET ScanImaging will begin 50-100 minutes after injection and last about 45 minutes. | Procedure or surgery | Cohort 1: Liver Fibrosis, Cohort 2: Pulmonary Fibrosis, Cohort 3: Myocardial Fibrosis |
Primary outcome
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.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas A Hope, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-FAP-2286 and Positron Emission Tomography (PET) in people with Liver Fibrosis and Pulmonary Fibrosis, run by Thomas Hope at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with treatment-related adverse events (time frame: Up to 31 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.