NCT03183570

Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT

Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 With [18F]FP-R01-MG-F2 With PET/CT

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 with \[18F\]FP-R01-MG-F2 with PET/CT

Detailed description

Stanford University has developed a new PET tracer, \[18F\]FP-R01-MG-F2, that selectively binds to integrin avb6, a cell surface receptor that is overexpressed in idiopathic pulmonary fibrosis (IPF). Increased avb6 receptors on IPF lung tissue has been well documented, while its expression remains relatively non-existent in the healthy adult lung. The PET tracer's application will be expanded in primary sclerosing cholangitis (PSC) and COVID-19 pneumonia. The integrin avb6 is also up-regulated in the biliary epithelial cells, which drive the progression of biliary tree strictures and liver fibrosis through activation of TGF-b, as shown in IPF. Similarly, COVID-19 pneumonia is caused by the SARS-CoV-2 and leads to acute lung injury and integrin avb6 up-regulation. The selected PET tracer \[18F\]FP-R01-MG-F2 has shown promise in identifying integrin avb6 in both preclinical and clinical studies at Stanford University. The investigators have demonstrated low \[18F\]FP-R01-MG-F2 radiopharmaceutical uptake in the heart and lung region of healthy volunteers, which was an expected biodistribution (the normal tissue uptake of the radiopharmaceutical within the body) based on immunohistochemical staining of healthy lung tissue, which demonstrated the presence of minimal avb6 receptors in healthy lung tissue. OBJECTIVE: 1. Exploring the use of the investigational radiopharmaceutical \[18\]FFP-R01-MG-F2 as a biomarker for avb6 integrin in fibrotic lung tissue. 2. Exploring the use of the investigational radiopharmaceutical \[18\]FFP-R01-MG-F2 to access inflammation and fibrosis in the bile duct and liver. 3. Exploring the use of the investigational radiopharmaceutical \[18\]FFP-R01-MG-F2 to assess lung injury in COVID-19 pneumonia. The performance of \[18F\]FP-R01-MG-F2 PET/CT will be assessed in a cohort of up to 13-15 IPF patients, 5 PSC patients, 5 COVID19 pneumonia patients, and 5 age-matched healthy controls. Feasibility will be measured by drawing regions of interest (ROI) around the lung/ liver of participants with IPF, COVID19, or PSC, respectively, and the lungs of healthy adult volunteers and comparing the calculated standardized uptake value maximum(s) (SUV max). The tracer's biodistribution, safety, and tolerability will also be studied. Recruitment of IPF subjects and healthy volunteers has been completed, although recruitment for other aspects of this clinical trial is ongoing.

Conditions

• Idiopathic Pulmonary Fibrosis
• Primary Sclerosing Cholangitis
• Covid19 Pneumonia

Interventions

Type	Name	Description
DRUG	[18F]FP-R01-MG-F2	7mCi (range 6-9mCi) \[18F\]FP-R01-MG-F2 will be administered

Timeline

• Start date: 2017-11-08
• Primary completion: 2023-04-25
• Completion: 2025-01-25
• First posted: 2017-06-12
• Last updated: 2025-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study