Covid19 Pneumonia, Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis
Conditions
Brief 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.
Interventions
7mCi (range 6-9mCi) \[18F\]FP-R01-MG-F2 will be administered
Sponsors
Pliant Therapeutics, Inc.
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1.0 Eligibility Criteria for IPF Patients 1.1 Inclusion Criteria The following inclusion criteria will be monitored: * Patient is \>/= 18 years old * Patient is capable of making an informed decision regarding his/her treatment * Patient diagnosed with IPF by a pulmonologist according to ATS guidelines * Patient has high-resolution CT with definite Usual Interstitial Pneumonia (UIP) pattern * Patient has PFT's within the last 12 months with: * FVC\<85% predicted * DLCO\<65% predicted * FEV1/FCV ratio \>70% * Patient is able to comply with study procedures * Scanning Option A OR * Scanning Option B 1.2
Exclusion criteria
The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SUV max comparison : IPF versus Healthy Lung, PSC versus Healthy Liver, COVID19 versus Healthy Lung | an estimated average of 2 hours | The SUVmax in a lung or liver with known IPF, COVID19 pneumonia, or PSC respectively will be compared to the SUVmax in a known healthy lung/liver. It is expected that the SUV max, which is a measurement of the maximum value of radiopharmaceutical uptake within the region of interest (ROI) in IPF, COVID19 pneumonia, and PSC will be higher than the SUV max in the healthy lung/liver. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Activity Measurements | an estimated average of 1 hours | Blood samples for blood time-activity measurements taken at 1, 3, 5, 10, 30, and 60 minutes after tracer injection for tracer kinetic analysis. Tracer kinetic analysis shows radiopharmaceutical distribution from the blood to the tissues over time. |
| Incidence of Study Completion (Safety and Tolerability) | an estimated average of 2 hours | Vital signs and laboratory data collected before IV injection of \[18F\]FP-R01-MG-F2 and after completion of the scan will allow the investigators to evaluate the safety and tolerability of the radiopharmaceutical. This will be measured as the number of patients who successfully completed the study. |
Countries
United States
Outcome results
None listed