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Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis and Primary Sclerosing Cholangitis Using PET/CT

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ClinicalTrials.gov Identifier: NCT03183570
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
Pliant Therapeutics, Inc.
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University

Brief Summary:
Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis and Primary Sclerosing Cholangitis with [18F]FP-R01-MG-F2 PET/CT

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Primary Sclerosing Cholangitis 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.

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.

OBJECTIVE:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


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 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).

Drug: [18F]FP-R01-MG-F2
7mCi (range 6-9mCi) [18F]FP-R01-MG-F2 will be administered




Primary Outcome Measures :
  1. 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.


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, 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.

  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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  1. Eligibility Criteria for IPF Patients

    1.1 Inclusion Criteria

    • Patient is >/= 18 years old
    • Patient is capable of making an informed decision regarding his/her treatment
    • 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 (8 +8 mins)

    1.2 Exclusion Criteria

    • Patients with a 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 a pulmonologist
    • Patient has had a lung infection of any kind in the last 3 months
    • Patient is pregnant or lactating
  2. Eligibility Criteria for PSC Patients

    2.1 Inclusion Criteria:

    • Patient is >/= 18 years old
    • Patient is capable of making an informed decision regarding his/her treatment
    • Patient diagnosed with large duct PSC, based on an abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), and/or percutaneous transhepatic cholangiopancreatography (PTC) in the context of cholestatic liver chemistry
    • Patient is able to comply with study procedures o Scanning Option C (8 +8 mins)

    2.2 Exclusion Criteria:

    • Patients with a serious uncontrolled concurrent medical illness that would limit compliance with study requirements
    • Patient has other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
    • Patient has a history of ascending cholangitis within 60 days of screening, as assessed clinically
    • Patient has history, current clinical or radiological suspicion, or diagnosis of cholangiocarcinoma, other hepatobiliary malignancy, colorectal cancer, or other abdominal malignancy at any time
    • Presence of a percutaneous drain or bile duct stent
    • Patient is pregnant or lactating
  3. Eligibility Criteria for Healthy Control

3.1 Inclusion Criteria:

  • Person is >/= 45 years old
  • Person is capable of making an informed decision regarding his/her treatment
  • Person is able to comply with study procedures

    • Scanning Option A (60 + 20 + 20 mins) OR
    • Scanning Option B (8 + 8 mins)

3.2 Exclusion Criteria:

  • Person with a serious uncontrolled concurrent medical illness that would limit compliance with study requirements
  • Person has a history of any clinically significant lung disease other than IPF as determined by a pulmonologist
  • Person had lung infection of any kind in the last 3 months
  • Person is pregnant or lactating

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: Andrea Otte, DPT (650) 736-4183 anotte@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Andrea Otte, DPT    650-736-4183    anotte@stanford.edu   
Sub-Investigator: Joshua Mooney, MD, MS         
Sub-Investigator: Tushar Desai, MD, MPH         
Sub-Investigator: Henry Guo, MD, PhD         
Sub-Investigator: Aparna Goel, MD         
Sponsors and Collaborators
Stanford University
Pliant Therapeutics, Inc.
Investigators
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Study Director: Henry Guo, 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    
Other Study ID Numbers: IRB Protocol: 40450
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
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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Cholangitis
Cholangitis, Sclerosing
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases