Interstitial Lung DiseaseEarly Phase 1FAPI ILDNCT05365802
FAPI PET for Lung Fibrosis
A Early Phase 1 study testing 68Ga-FAPi-46, Computed Tomography and Positron Emission Tomography in people with Interstitial Lung Disease and Idiopathic Interstitial Pneumonias, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Idiopathic Interstitial Pneumonias, Drug-Induced Pneumonitis
- What is being tested?
- 68Ga-FAPi-46, Computed Tomography and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Patients with ILD confirmed by CT at time of staging
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation.
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.
Read more
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.
Read the 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.
OUTLINE:
- Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT and one High Resolution CT of the lungs
- Patients will be followed until pathology is obtained during clinical care. (if undergoing surgery or biopsy)
- Biodistribution results will be assessed comparing pathological findings and PET/CT results
- Conditions
- Interstitial Lung Disease, Idiopathic Interstitial Pneumonias, Drug-Induced Pneumonitis, Hypersensitivity Pneumonitis, Radiation Pneumonitis, Pneumoconiosis
- Being tested
- 68Ga-FAPi-46, Computed Tomography, Positron Emission Tomography, High Resolution Computed Tomography
- Keywords
- interstitial lung disease, pulmonary fibrosis, 68Ga-FAPi-46
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Interstitial Pneumonias, Alveolitis, Extrinsic Allergic, Radiation Pneumonitis, Pneumoconiosis, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPi-46Drug
Also called Gallium-68-FAPi-46
Radiopharmaceutical will be administered via IV
Computed TomographyProcedure or surgery
Also called CT scan
As part of PET/CT scan
Positron Emission TomographyProcedure or surgery
Also called PET scan
As part of PET/CT scan
High Resolution Computed TomographyProcedure or surgery
Will be conducted immediately after FAPI PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPi-46 | Experimental | Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes Receives: Drug: 68Ga-FAPi-46; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: High Resolution Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in patients with Interstitial Lung Disease
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)).
Measured: 60 minutes following injection
Secondary outcomes (3)
68Ga-FAPi-46 accumulation
To evaluate the degree of 68Ga-FAPi-46 accumulation observed by PET imaging as opposed to the amount of FAP expression in obtained lung tissue, when available. 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.
Measured: Up to 2 years
68Ga-FAPi-46 and disease progression
To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with disease progression under ILD therapies.
Measured: Up to 2 years
68Ga-FAPi-46 biodistribution
To evaluate whether the 68Ga-FAPi-46 biodistribution in the lungs can be associated with HR CT quantitative parameters
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start16 Nov 2021
- Primary completion1 Jul 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremie Calais, University of California, Los Angeles
- Investigators
- Jeremie Calais, MD, Principal investigator, Clinical Research Director, Ahmanson Translational Theranostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365802
- Sponsor's protocol ID
- IRB21-000678
- Acronym
- FAPI ILD
- Status last verified
- Aug 2026
- First submitted
- 22 Apr 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hotta M, Kim GHJ, Rerkpichaisuth V, Teng PY, Armstrong WR, Carlucci G, Dahlbom M, Abtin F, Lari SM, Fishbein GA, Czernin J, Volkmann ER, Weigt SS, Calais J. Correlation of FAPI PET Uptake with Immunohistochemistry in Explanted Lungs from Patients with Advanced Interstitial Lung Disease. J Nucl Med. 2024 Nov 1;65(11):1789-1794. doi: 10.2967/jnumed.124.268351.
PubMed 39362770
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Study of 68Ga-FAPi-46 in Patients With Interstitial Lung Disease: an Exploratory Biodistribution Study With Histopathology Validation.
- ClinicalTrials.gov ID
- NCT05365802
- Acronym / sponsor ID
- FAPI ILD / IRB21-000678
- Conditions
- Interstitial Lung Disease, Idiopathic Interstitial Pneumonias, Drug-Induced Pneumonitis, Hypersensitivity Pneumonitis, Radiation Pneumonitis, Pneumoconiosis
- Keywords
- interstitial lung disease, pulmonary fibrosis, 68Ga-FAPi-46
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 May 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 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 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.
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.
OUTLINE:
- Participants with Interstitial Lung Disease will be asked to undergo a 68Ga-FAPi-46 PET/CT and one High Resolution CT of the lungs
- Patients will be followed until pathology is obtained during clinical care. (if undergoing surgery or biopsy)
- Biodistribution results will be assessed comparing pathological findings and PET/CT results
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPi-46 | Experimental | Drug: 68Ga-FAPi-46, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Procedure: High Resolution Computed TomographyPatients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ILD confirmed by CT at time of staging
- 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
Key exclusion criteria (3 listed)
- 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
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-FAPi-46Also: Gallium-68-FAPi-46Radiopharmaceutical will be administered via IV | Drug | 68Ga-FAPi-46 |
| Computed TomographyAlso: CT scanAs part of PET/CT scan | Procedure or surgery | 68Ga-FAPi-46 |
| Positron Emission TomographyAlso: PET scanAs part of PET/CT scan | Procedure or surgery | 68Ga-FAPi-46 |
| High Resolution Computed TomographyWill be conducted immediately after FAPI PET/CT | Procedure or surgery | 68Ga-FAPi-46 |
Primary outcome
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)).
3 secondary outcomes
68Ga-FAPi-46 accumulation
Time frame: Up to 2 years
68Ga-FAPi-46 and disease progression
Time frame: Up to 2 years
68Ga-FAPi-46 biodistribution
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 39362770Hotta M, Kim GHJ, Rerkpichaisuth V, Teng PY, Armstrong WR, Carlucci G, Dahlbom M, Abtin F, Lari SM, Fishbein GA, Czernin J, Volkmann ER, Weigt SS, Calais J. Correlation of FAPI PET Uptake with Immunohistochemistry in Explanted Lungs from Patients with Advanced Interstitial Lung Disease. J Nucl Med. 2024 Nov 1;65(11):1789-1794. doi: 10.2967/jnumed.124.268351.
- 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.
Jeremie Calais, MD principal investigator
Clinical Research Director, Ahmanson Translational Theranostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-FAPi-46, Computed Tomography and Positron Emission Tomography in people with Interstitial Lung Disease and Idiopathic Interstitial Pneumonias, run by University of California, Los Angeles 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05365802, which also lists 1 linked publication.
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 20 Aug 2026.