What side effects are associated with this type of intervention?

The most common treatments for idiopathic pulmonary fibrosis (IPF) include antifibrotic agents such as nintedanib and pirfenidone. Nintedanib is associated with side effects like diarrhea, nausea, liver enzyme elevation, and abdominal pain. Pirfenidone commonly causes nausea, rash, fatigue, and gastrointestinal discomfort. Both medications aim to slow disease progression but do not cure the condition. Patients should discuss potential side effects and management strategies with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved two main drugs for the treatment of idiopathic pulmonary fibrosis (IPF): nintedanib and pirfenidone. Nintedanib is a tyrosine kinase inhibitor that targets multiple growth factors involved in fibrosis, such as platelet-derived growth factor, vascular endothelial growth factor, and fibroblast growth factor. Pirfenidone is an antifibrotic agent that reduces fibroblast proliferation, production of fibrosis-associated proteins, and cytokine production. Both drugs aim to slow disease progression but are not curative. While these treatments do not specifically target Fibroblast Activation Protein (FAP) like the imaging agent 68Ga-FAP-2286, they address the fibrotic processes in IPF.

What other types of research exist?

Promising novel alternatives to 68Ga-FAP-2286 for pulmonary fibrosis patients include: 1) Hemoperfusion with polymyxin-B immobilized fiber, which has shown improvement in oxygenation and survival rates in patients with acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). 2) Tacrolimus, which has demonstrated survival benefits when used with methylprednisolone pulse therapy in AE-IPF patients. However, recombinant human soluble thrombomodulin alpha (rhTM) should not be used due to lack of survival benefit and higher bleeding risk.

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Peptide

FAP-2286 PET Imaging for Fibrosis

Phase 1

Recruiting

Led By Thomas A Hope, MD

Research Sponsored by Thomas Hope

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 31 days

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special imaging agent to detect scarring in the liver, lungs, and heart. It targets patients with these specific types of scarring because traditional imaging might not be as effective. The agent works by binding to a protein found in scarred tissues, making them visible on a PET scan.

Who is the study for?

This trial is for adults with confirmed pathologic fibrosis affecting the liver, lungs, or heart. Participants must understand and sign a consent form. It's not suitable for pregnant individuals or those unlikely to follow the trial procedures.

What is being tested?

The study tests a new imaging agent called 68Ga-FAP-2286 using PET scans to detect fibrosis in the liver, lungs, and heart. The agent binds to proteins that are more common in these types of fibrosis.

What are the potential side effects?

Since this is an imaging study primarily involving PET scans and a novel tracer (68Ga-FAP-2286), side effects may include reactions at the injection site or allergic responses but will be detailed as data becomes available.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 31 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 31 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 31 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median peak standardized uptake value (SUV) in myocardium region

Liver

Lung

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3: Myocardial FibrosisExperimental Treatment2 Interventions

Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.

Group II: Cohort 2: Pulmonary FibrosisExperimental Treatment2 Interventions

Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.

Group III: Cohort 1: Liver FibrosisExperimental Treatment2 Interventions

Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography (PET)

2018

Completed Phase 4

~1540

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pulmonary Fibrosis treatments often target the activity of fibroblasts and the signaling pathways that promote fibrosis. Nintedanib, a tyrosine kinase inhibitor, blocks multiple growth factors (e.g., PDGF, VEGF, FGF) that drive fibroblast proliferation and matrix deposition. Pirfenidone, another antifibrotic agent, reduces fibroblast activity and collagen synthesis through its anti-inflammatory and antioxidant properties. These treatments are crucial for PF patients as they help slow disease progression by mitigating the excessive fibrotic response. The trial involving 68Ga-FAP-2286, which selectively binds to Fibroblast Activation Protein (FAP) for imaging, underscores the importance of targeting fibroblast activity in managing PF.

Scarred Lung. An Update on Radiation-Induced Pulmonary Fibrosis.