FAPI PET for Lung Fibrosis

(FAPI ILD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jeremie Calais, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of California, Los Angeles

Must be taking: Ild medications

Disqualifiers: Pregnancy, Infectious lung disease, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants may have started or will start a new medication for their lung condition.

What data supports the effectiveness of the treatment 68Ga-FAPi-46 for lung fibrosis?

Research shows that fibroblast activation protein inhibitors (FAPI) like 68Ga-FAPi-46 are useful in imaging and detecting disease activity in conditions with fibroblast proliferation, such as pulmonary fibrosis and various cancers. This suggests potential effectiveness in monitoring lung fibrosis. ^{1 2 3 4 5}

Is 68Ga-FAPI-46 safe for use in humans?

68Ga-FAPI-46 and similar compounds have been used in various studies for imaging in cancer and other conditions, showing promising results without specific safety concerns reported in the provided research. ^{2 3 5 6 7}

How is the drug 68Ga-FAPi-46 different from other treatments for lung fibrosis?

68Ga-FAPi-46 is unique because it uses a special imaging technique called PET (positron emission tomography) to detect active fibroblasts (cells involved in tissue scarring) in lung fibrosis, which helps monitor disease activity and treatment response. This approach is different from traditional treatments that do not provide such detailed imaging information. ^{1 2 3 4 5}

Research Team

Jeremie Calais, MD

Principal Investigator

Clinical Research Director, Ahmanson Translational Theranostics

Eligibility Criteria

This trial is for adults over 18 with interstitial lung disease (ILD), confirmed by a CT scan within the last 3 months. Participants must be starting new ILD medication soon or scheduled for lung biopsy or surgery. Pregnant or nursing individuals, those with active infectious lung disease, and anyone unable to follow the study plan are excluded.

Inclusion Criteria

Patients are ≥ 18 years old at the time of the radiotracer administration

Patient can provide written informed consent

Patients with ILD confirmed by CT at time of staging within 3 months

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for biodistribution results and correlation with pathology findings

Up to 2 years

Treatment Details

Interventions

• 68Ga-FAPi-46 (Radiopharmaceutical)

Trial Overview The study tests how a tracer called 68Ga-FAPI-46 distributes in normal versus fibrotic lung tissues in ILD patients. Each participant will receive an injection of this tracer followed by one PET/CT scan and one high-resolution CT of their lungs to track the tracer's accumulation.

Participant Groups

Group I: 68Ga-FAPi-46 Experimental Treatment 4 Interventions

Patients receive 68Ga-FAPi-46 IV and undergo PET/CT scan over 20-50 minutes

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

Findings from Research

FAPI PET imaging using [68Ga]Ga-FAPI-46 was able to detect increased lung uptake in a mouse model of pulmonary fibrosis at both 7 and 14 days post-bleomycin administration, indicating its potential as a biomarker for disease activity.

In contrast, traditional CT imaging only identified differences in fibrosis at 14 days, highlighting FAPI PET's superior ability to assess early disease activity and response to treatment in idiopathic pulmonary fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[68&#160;Ga]Ga-FAPI-46 PET for non-invasive detection of pulmonary fibrosis disease activity. Rosenkrans, ZT., Massey, CF., Bernau, K., et al.[2022]

68Ga-FAPI-04 is an effective PET imaging agent that can help diagnose conditions like IgG4-related disease (IgG4-RD) by targeting fibroblast activation protein, which is often present in tumors and inflammatory tissues.

In a case study of a 62-year-old patient, 68Ga-FAPI PET provided clearer diagnostic information than traditional 18F-FDG PET, highlighting its potential to differentiate between pancreatitis and pancreatic cancer when other imaging results are inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 PET/MR is helpful in differential diagnosis of pancreatitis from pancreatic malignancy compared to 18F-FDG PET/CT: a case report. Shou, Y., Xue, Q., Yuan, J., et al.[2021]

In a study involving 54 cancer patients, [68Ga]Ga-DOTA.SA.FAPi showed comparable effectiveness to the standard [18F]F-FDG PET/CT scans in detecting various cancers, with both tracers demonstrating similar uptake in most metastatic regions.

[68Ga]Ga-DOTA.SA.FAPi exhibited significantly higher uptake ratios in brain metastases compared to normal brain tissue, suggesting its potential for better visualization of certain cancer types, while also showing a favorable safety profile with no significant adverse effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biodistribution, pharmacokinetics, dosimetry of [68Ga]Ga-DOTA.SA.FAPi, and the head-to-head comparison with [18F]F-FDG PET/CT in patients with various cancers. Ballal, S., Yadav, MP., Moon, ES., et al.[2021]

68Ga-labeled quinoline-based fibroblast activation protein inhibitors (68Ga-FAPIs) are effective for tumor imaging, but can also show increased uptake in noncancerous conditions.

A case study highlighted that a patient with polyostotic fibrous dysplasia exhibited intense metabolic activity on 68Ga-FAPI PET/CT, indicating that this condition can mimic tumor activity and may lead to misinterpretation of imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 PET/CT Imaging for Fibrous Dysplasia of the Bone. Wang, Y., Wu, J., Liu, L., et al.[2023]

FAPI PET/CT demonstrated a remarkable sensitivity of 100% for detecting primary and recurrent colorectal cancers (CRCs), significantly outperforming FDG PET/CT and conventional imaging, which had a sensitivity of 88%.

Overall, FAPI PET/CT achieved an accuracy of 95% in evaluating CRCs, particularly excelling in identifying peritoneal metastasis (96% sensitivity) compared to only 66% for FDG, suggesting that FAPI could potentially replace FDG in clinical practice for CRC assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of Ga-68 FAPI 04 PET/CT in colorectal malignancies. Prashanth, A., Kumar Ravichander, S., Eswaran, P., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cardiac fibroblast activation detected by Ga-68 FAPI PET imaging as a potential novel biomarker of cardiac injury/remodeling. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[68&#160;Ga]Ga-FAPI-46 PET for non-invasive detection of pulmonary fibrosis disease activity. [2022]

3. England pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 PET/MR is helpful in differential diagnosis of pancreatitis from pancreatic malignancy compared to 18F-FDG PET/CT: a case report. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The Role of 68 Ga-FAPI PET/CT in Breast Cancer Response Assessment and Follow-Up. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Biodistribution, pharmacokinetics, dosimetry of [68Ga]Ga-DOTA.SA.FAPi, and the head-to-head comparison with [18F]F-FDG PET/CT in patients with various cancers. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 PET/CT Imaging for Fibrous Dysplasia of the Bone. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Diagnostic performance of Ga-68 FAPI 04 PET/CT in colorectal malignancies. [2023]