FAPI ILD: FAPI PET for Lung Fibrosis
Study Details
Study Description
Brief Summary
This is a prospective exploratory biodistribution study in patients with interstitial lung disease (ILD).
The purpose of this research study is to determine where and to which degree the FAPI tracer (68Ga-FAPI-46) accumulates in normal and fibrotic lung tissues of patients with interstitial lung disease.
The study will include patients with interstitial lung disease with fibrotic lesions who are scheduled to undergo lung biopsy or transplantation.
The study will include 30 patients, the upper limit for PET imaging studies conducted under the Radioactive Drug Research Committee (RDRC) purview.
Participants will be injected with up to 7 mCi of 68-GaFAPi and will undergo one PET/CT scan.
The study is sponsored by Ahmanson Translational Theranostic Division at UCLA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Early Phase 1 |
Detailed Description
ILD is a group of respiratory diseases that affect the interstitium of the lungs. A major problem is the highly variable course of fibrosing ILD: some patients remain stable without treatment, and others progress rapidly despite pharmacotherapy.
Novel diagnostic approaches for risk stratification with more accurate prediction of the course of fibrosing ILD could potentially improve prognostication and ultimately lead to better survival in these patients.
Persistent activation and local accumulation of myofibroblasts is a common feature of fibrotic diseases. FAP is a promising target for molecular imaging of fibroblast activation and detection of sites of active tissue remodeling.
Small molecule inhibitors of FAP have been labeled with positron-emitting isotopes for PET imaging. 68Ga-FAPi-46 can serve as diagnostic biomarker in ILD.
In this study, the investigators will evaluate the 68Ga-FAPi-46 biodistribution in patients with ILD and observe the correlation of FAP expression and FAPi radiopharmaceutical uptake.
The primary objective of this study is to evaluate the biodistribution of the new FAP-targeted PET tracer, 68Ga-FAPi- 46, in patients with ILD who are scheduled for lung biopsy or transplantation.
The biodistribution will be validated by histopathology and immunohistochemistry from obtained lung tissue.
OUTLINE:
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Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT
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Patients will be followed until pathology is obtained during clinical care.
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Biodistribution results will be assessed comparing pathological findings and PET/CT results
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 68Ga-FAPi-46 Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes |
Drug: 68Ga-FAPi-46
Radiopharmaceutical will be administered via IV
Other Names:
Procedure: Computed Tomography
As part of PET/CT scan
Other Names:
Procedure: Positron Emission Tomography
As part of PET/CT scan
Other Names:
|
Outcome Measures
Primary Outcome Measures
- To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease [60 minutes following injection]
To quantify diseased tissue and normal background organs, 68Ga-FAPI-46 positron emission tomography (PET) tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).
Secondary Outcome Measures
- 68Ga-FAPi-46 accumulation [Up to 2 years]
To correlate PET imaging signal with fibroblast activation protein (FAP) expression by immunohistochemistry (IHC). 68Ga-FAPi-46 SUVs will be correlated with FAP expression from surgically resected tissue. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients with the following ILD:
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Idiopathic interstitial pneumonia
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Connective tissue disease related intestitial lung disease (CTD-ILD)
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Drug-induced pneumonitis
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Hypersensitivity pneumonitis
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Radiation pneumonitis
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Pneumoconiosis
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Post-COVID-19 pulmonary fibrosis
Patients with fibrotic lung lesion confirmed by HRCT performed within 6 months. Patients who are scheduled to undergo tissue biopsy or surgery of the lung. Patients are ≥ 18 years old at the time of the radiotracer administration. Patient can provide written informed consent.
Exclusion Criteria:
Patient is pregnant or nursing. Patients with active infectious lung disease. Patients not expected to comply with the protocol requirements, not able to understand or follow trial procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
- Principal Investigator: Jeremie Calais, MD, Clinical Research Director, Ahmanson Translational Theranostics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB21-000678