Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis Using PET/CT

Study Purpose

The investigators wish to evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in patients with Idiopathic Pulmonary Fibrosis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

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 60 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from, 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
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Stanford University
Principal Investigator

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
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

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.

Arms & Interventions


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.


Drug: - [18F]FP-R01-MG-F2

7mCi (range 6-9mCi) [18F]FP-R01-MG-F2 will be administered to patients with IPF

Contact a Trial Team

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Stanford University, Stanford, California




Stanford University

Stanford, California, 94305

Site Contact

Andrea Otte


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