Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis and Primary Sclerosing Cholangitis Using PET/CT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03183570|
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis Primary Sclerosing Cholangitis||Drug: [18F]FP-R01-MG-F2||Early Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis and Primary Sclerosing Cholangitis With [18F]FP-R01-MG-F2 PET/CT|
|Actual Study Start Date :||November 8, 2017|
|Estimated Primary Completion Date :||April 14, 2021|
|Estimated Study Completion Date :||December 15, 2021|
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).
7mCi (range 6-9mCi) [18F]FP-R01-MG-F2 will be administered
- SUV max comparison : IPF versus Healthy Lung, PSC versus Healthy Liver [ Time Frame: an estimated average of 2 hours ]The SUVmax in a lung or liver with known IPF 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 and PSC will be higher than the SUV max in the healthy lung/liver.
- Time Activity Measurements [ Time Frame: an estimated average of 2 hours ]Blood samples for blood time activity measurements taken at 1, 3, 5, 10, 30, and 60 minutes after tracer injection, and then at every 30 minute intervals up to 2 hours after tracer injection will allow 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) [ Time Frame: an estimated average of 2 hours ]EKG data, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183570
|Contact: Andrea Otte, DPT||(650) firstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Andrea Otte, DPT 650-736-4183 email@example.com|
|Sub-Investigator: Joshua Mooney, MD, MS|
|Sub-Investigator: Tushar Desai, MD, MPH|
|Sub-Investigator: Henry Guo, MD, PhD|
|Sub-Investigator: Aparna Goel, MD|
|Study Director:||Henry Guo, MD, PhD||Stanford University|