Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis Using PET/CT
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 4/17/2018 |
| Start Date: | November 8, 2017 |
| End Date: | May 15, 2020 |
| Contact: | Lacey Greene, BS, CNMT |
| Email: | lacey.greene@stanford.edu |
| Phone: | 6507254712 |
Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis With [18F]FP-R01-MG-F2 PET/CT
The investigators wish to evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in
patients with Idiopathic Pulmonary Fibrosis.
patients with Idiopathic Pulmonary Fibrosis.
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.
OBJECTIVE:
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.
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.
OBJECTIVE:
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.
Inclusion Criteria:
- Patient is >/= 60 years old
- Patient provides written informed consent
- 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 (60 +20 +20 mins) OR
- Scanning Option B (10 +10 mins)
Exclusion Criteria:
- Patients with serious uncontrolled concurrent medical illness that would limit
compliance with study requirements
- Patient has a history of any clinically significant lung disease other than IPF as
determined by pulmonologist
- Patient has had a lung infection of any kind in the last 3 months
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