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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
Sponsor:
Collaborator:
Pliant Therapeutics, Inc.
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University

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

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: [18F]FP-R01-MG-F2 Early Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Lacey Greene, BS, CNMT 6507254712 lacey.greene@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Omar Rutledge, MS       orutledge@stanford.edu   
Contact: Lacey Greene, BS    6507254712    lacey.greene@stanford.edu   
Sub-Investigator: Shyam Srinivas, MD, PhD         
Sub-Investigator: Joshua Mooney, MD, MS         
Sub-Investigator: Tushar Desai, MD, MPH         
Sponsors and Collaborators
Stanford University
Pliant Therapeutics, Inc.
Investigators
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Study Director: Shyam Srinivas, MD, PhD Stanford University

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Responsible Party: Sanjiv Sam Gambhir, Chair, Department of Radiology; Director, Molecular Imaging Program, Stanford University
ClinicalTrials.gov Identifier: NCT03183570     History of Changes
Other Study ID Numbers: IRB Protocol: 40450
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial