FAPI PET for Lung Fibrosis

(FAPI ILD Trial)

Overseen By Stephanie Lira

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Los Angeles

Must be taking: Ild medications

Disqualifiers: Pregnancy, Infectious lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe how a special tracer, 68Ga-FAPi-46 (Fibroblast Activation Protein Inhibitor), moves and accumulates in the lungs of individuals with interstitial lung disease (ILD). ILD can cause lung scarring, and this study examines the tracer's behavior in both normal and scarred lung tissue. Ideal participants are those diagnosed with ILD who have started or will soon start a new ILD medication, or who are scheduled for lung biopsy or surgery. During the trial, participants will receive the tracer via injection, followed by detailed lung scans to track the tracer’s location. This research could enhance understanding of ILD and its treatments. As an Early Phase 1 trial, the study focuses on understanding the tracer's function in people, offering participants a chance to contribute to groundbreaking insights into ILD.

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 prior data suggests that the FAPI tracer is safe for use in patients with interstitial lung disease?

Research shows that 68Ga-FAPi-46 PET scans are generally safe for people. Studies have found that this tracer, which helps detect certain proteins in the body, is well-tolerated. For instance, cancer imaging research demonstrated that 68Ga-FAPi-46 was safe and did not cause serious side effects. This suggests it might also be safe for detecting lung fibrosis.

This study is an early phase trial, focusing on understanding how the tracer works in the body rather than treating a condition. Early phase trials aim to ensure safety and find the best dose without causing harm. Although less data exists specifically for lung fibrosis, existing cancer studies provide some confidence in the safety of 68Ga-FAPi-46. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for lung fibrosis, which often focus on managing symptoms or slowing disease progression, 68Ga-FAPi-46 offers a new approach by targeting fibroblast activation protein (FAP) in the affected lung tissue. This innovative method involves using a PET/CT scan to visualize FAP expression, which could provide more precise information about the disease's activity. Researchers are excited about this treatment because it might help tailor therapies more effectively and monitor the disease with greater accuracy, potentially leading to better outcomes for patients.

What evidence suggests that this tracer is effective for lung fibrosis?

Research has shown that the FAPI PET scan, using the 68Ga-FAPi-46 tracer, could aid in detecting lung fibrosis. In this trial, participants will receive the 68Ga-FAPi-46 tracer and undergo a PET/CT scan. Studies have found that this tracer can identify active disease in lung fibrosis models by targeting a protein linked to fibrosis, called fibroblast activation protein (FAP). By highlighting areas with fibrotic tissue, the scan can help track disease progression. This method offers a new way to assess lung fibrosis and may enhance how doctors monitor the condition. ^{1 2 5 6 7}

Who Is on the Research Team?

Jeremie Calais, MD

Principal Investigator

Clinical Research Director, Ahmanson Translational Theranostics

Are You a Good Fit for This Trial?

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

Patient can provide written informed consent

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

You have started or plan to start taking medication for interstitial lung disease within the last 3 months OR you are scheduled to have a lung tissue biopsy or surgery.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-FAPi-46

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.

How Is the Trial Designed?

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

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

68Ga-FAPi-46 is already approved in United States for the following indications:

Approved in United States as 68Ga-FAPI-46 for:

• Research use in interstitial lung disease (ILD)

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

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]

In a study of 32 cancer patients undergoing Ga-68 FAPI PET scans, 18.8% showed increased myocardial uptake of the tracer, indicating potential cardiac involvement that may be linked to underlying coronary artery disease (CAD).

The study found significant correlations between myocardial FAPI uptake and factors such as age, coronary artery disease, and left ventricular ejection fraction, suggesting that FAPI imaging could help in assessing cardiac risk and monitoring heart health in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac fibroblast activation detected by Ga-68 FAPI PET imaging as a potential novel biomarker of cardiac injury/remodeling. Siebermair, J., Köhler, MI., Kupusovic, J., et al.[2023]

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]

The study involved 6 patients with invasive lobular breast cancer who underwent 24 scans, showing that the 68 Ga-FAPI PET/CT radiotracer effectively correlates tumor volume with blood biomarkers, indicating its potential for monitoring cancer progression and treatment response.

While 68 Ga-FAPI showed a strong correlation with blood biomarkers (r = 0.7, P < 0.01), it had a weaker correlation with traditional CT imaging, suggesting that FAPI may provide additional insights into tumor behavior that standard imaging might miss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of 68 Ga-FAPI PET/CT in Breast Cancer Response Assessment and Follow-Up. Eshet, Y., Tau, N., Levanon, K., 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9553066/

[68Ga]Ga-FAPI-46 PET for noninvasive detection of ... The ability of FAPI PET to successfully detect both presence and disease activity in a murine model of pulmonary fibrosis makes it a promising tool for clinical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12240757/

68Ga-FAPI PET/CT for diagnostic accuracy and therapeutic ... This study aimed to assess the diagnostic and therapeutic monitoring potential of 68Ga-fibroblast-activating protein inhibitor (FAPI) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1568997225001168

Radio-labelled fibroblast activation protein inhibitors in ... This review examines the association between pulmonary FAPI tracer uptake, fibrotic activity, and clinical parameters used for disease monitoring and ...

4. nature.com nature.com/articles/s44303-024-00053-z

Clinical applications of fibroblast activation protein inhibitor ... One study demonstrated that SUVmax and TBR of 68Ga-FAPI-04 correlated with clinical outcomes (T) and lymph nodal status (N), which suggested ...

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1393778/full

The fibroblast activation protein alpha as a biomarker of ... In this review, we discuss the use of FAPα as a useful biomarker for the progression of lung fibrosis, by both its assessment in human fluids and/or its ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/64/8/1210

Clinical Evaluation of 68 Ga-FAPI-RGD for Imaging of ... This study demonstrated the safety and clinical feasibility of 68 Ga-FAPI-RGD PET/CT for imaging of various types of cancer.

7. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.220749

FAPI PET: Fibroblast Activation Protein Inhibitor Use in ... Among the FAP-based radiotracers developed so far, gallium 68 (68Ga)–labeled FAPIs provide the most favorable imaging features in terms of high ...