Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis Using PET/CT
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|ClinicalTrials.gov Identifier: NCT03183570|
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||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.
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.
To evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in patients with IPF. Feasibility will be measured by drawing regions of interest (ROI) around the lungs of participants with IPF and the lungs of healthy adult volunteers and comparing the calculated standarized uptake value maximum(s) (SUVmax).
The tracer's physiologic biodistribution, safety and tolerability will also be studied.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis With [18F]FP-R01-MG-F2 PET/CT|
|Actual Study Start Date :||November 8, 2017|
|Estimated Primary Completion Date :||May 15, 2019|
|Estimated Study Completion Date :||May 15, 2020|
Experimental: [18F]FP-R01-MG-F2 PET/CT
7mCi (range 6-9 mCi) [18F]FP-R01-MG-F2 will be administered to patients with IPF, followed by a 60-minute dynamic PET/CT scan of the lung field of view and two vertex-to-thigh PET/CT scans.
7mCi (range 6-9mCi) [18F]FP-R01-MG-F2 will be administered to patients with IPF
- SUV max comparison : IPF versus Healthy Lung [ Time Frame: an estimated average of 2 hours ]The SUVmax in a lung with known IPF will be compared to the SUVmax in a known healthy lung. 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 will be higher than the SUV max in the healthy lung.
- Time Activity Measurements [ Time Frame: an estimated average of 2 hours ]Blood samples for blood time activity measurements taken at 1, 3, 5, and 10 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: Lacey Greene, BS, CNMTfirstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Omar Rutledge, MS email@example.com|
|Contact: Lacey Greene, BS 6507254712 firstname.lastname@example.org|
|Sub-Investigator: Shyam Srinivas, MD, PhD|
|Sub-Investigator: Joshua Mooney, MD, MS|
|Sub-Investigator: Tushar Desai, MD, MPH|
|Study Director:||Shyam Srinivas, MD, PhD||Stanford University|