Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2021-11-16
2026-12-31
Brief Summary
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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 who have or will initiate a new ILD medication OR will undergo tissue biopsy or surgery of the lung.
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 and one High Resolution CT of the lungs.
The study is sponsored by Ahmanson Translational Theranostic Division at UCLA.
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Detailed Description
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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.
OUTLINE:
1. Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT and one High Resolution CT of the lungs
2. Patients will be followed until pathology is obtained during clinical care. (if undergoing surgery or biopsy)
3. Biodistribution results will be assessed comparing pathological findings and PET/CT results
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga-FAPi-46
Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes
68Ga-FAPi-46
Radiopharmaceutical will be administered via IV
Computed Tomography
As part of PET/CT scan
Positron Emission Tomography
As part of PET/CT scan
High Resolution Computed Tomography
Will be conducted immediately after FAPI PET/CT
Interventions
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68Ga-FAPi-46
Radiopharmaceutical will be administered via IV
Computed Tomography
As part of PET/CT scan
Positron Emission Tomography
As part of PET/CT scan
High Resolution Computed Tomography
Will be conducted immediately after FAPI PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have initiated or will initiate a new ILD medication with 3 months of enrollment OR 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
* Patients with active infectious lung disease
* Patients not expected to comply with the protocol requirements, not able to understand or follow trial procedures
18 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Jeremie Calais
Clinical Research Director, Ahmanson Translational Theranostics
Principal Investigators
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Jeremie Calais, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Director, Ahmanson Translational Theranostics
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Central Contacts
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Other Identifiers
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IRB21-000678
Identifier Type: -
Identifier Source: org_study_id
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