FAPI PET for Lung Fibrosis (FAPI ILD)
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|ClinicalTrials.gov Identifier: NCT05365802|
Recruitment Status : Recruiting
First Posted : May 9, 2022
Last Update Posted : May 12, 2022
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|
|Interstitial Lung Disease Idiopathic Interstitial Pneumonias Drug-Induced Pneumonitis Hypersensitivity Pneumonitis Radiation Pneumonitis Pneumoconiosis Pulmonary Fibrosis||Drug: 68Ga-FAPi-46 Procedure: Computed Tomography Procedure: Positron Emission Tomography||Early Phase 1|
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.
- Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT
- Patients will be followed until pathology is obtained during clinical care.
- Biodistribution results will be assessed comparing pathological findings and PET/CT results
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation.|
|Actual Study Start Date :||November 16, 2021|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||December 2023|
Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes
Radiopharmaceutical will be administered via IV
Other Name: Gallium-68-FAPi-46
Procedure: Computed Tomography
As part of PET/CT scan
Other Name: CT scan
Procedure: Positron Emission Tomography
As part of PET/CT scan
Other Name: PET scan
- To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease [ Time Frame: 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)).
- 68Ga-FAPi-46 accumulation [ Time Frame: 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.
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): NCT05365802
|Contact: Wesley R Armstrong, BSfirstname.lastname@example.org|
|Contact: Erin Y Shen, BSemail@example.com|
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Jeremie Calais, MD||Clinical Research Director, Ahmanson Translational Theranostics|