Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
1. Eligibility Criteria for IPF Patients 1.1 Inclusion Criteria
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Early Phase 1|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Henry Guo, MD, PhD|
|Principal Investigator Affiliation||Stanford University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis|
Stanford University has developed a new PET tracer 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. In primary sclerosing cholangitis (PSC), 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 has been shown in IPF. The selected PET tracer [18F]FP-R01-MG-F2 has shown promise 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. Similarily, radiopharmaceutical uptake in the hepatic and biliary region of healthy volunteers was low, suggesting that it may also be useful for the detection of increased avb6 in the bile ducts of cholestatic liver disease patients such as PSC. OBJECTIVE: 1) To evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in patients with Idiopathic Pulmonary Fibrosis and Primary Sclerosing Cholangitis We will evaluate [18F]FP-R01-MG-F2 for the detection of Idiopathic Pulmonary Fibrosis (IPF) and Primary Sclerosing Cholangitis (PSC). 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, and 5 age-matched healthy controls. Feasibility will be measured by drawing regions of interest (ROI) around the lung/ liver of participants with IPF or PSC, respectively, and the lungs of healthy adult volunteers and comparing the calculated standardized uptake value maximum(s) (SUVmax). The tracer's biodistribution, safety, and tolerability will also be studied.
Experimental: [18F]FP-R01-MG-F2 PET/CT
7mCi (range 6-9 mCi) [18F]FP-R01-MG-F2 will be administered to all study participants. IPF patients and healthy volunteers will have a 60-minute dynamic PET/CT scan to the center of the lungs in the FOV followed by two vertex-to-thigh PET/CT scans. PSC patients will have only two vertex-to-thigh PET/CT scans to the center of the liver in the FOV. Patients will have a repeat [18F]FP-R01-MG-F2 PET/CT scan performed within 3-8 weeks post initial scan (within 12-24 months post initial scan for previously scanned IPF patients if they are willing to be re-consented).
Drug: - [18F]FP-R01-MG-F2
7mCi (range 6-9mCi) [18F]FP-R01-MG-F2 will be administered
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.