Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT

Trial ID or NCT#

NCT03183570

Status

not recruiting iconNOT RECRUITING

Purpose

Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 with \[18F\]FP-R01-MG-F2 with PET/CT

Official Title

Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 With [18F]FP-R01-MG-F2 With PET/CT

Eligibility Criteria

Ages Eligible for Study: Older than 18
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. The following inclusion criteria will be monitored:
    1. * 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:
    2. * FVC\<85% predicted * DLCO\<65% predicted* FEV1/FCV ratio \>70%* Patient is able to comply with study procedures
    3. * Scanning Option A OR * Scanning Option B
      1. 1.2 Exclusion Criteria
  3. The following exclusion criteria will be monitored:
    1. * Patient 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
      1. 2.0 Eligibility Criteria for PSC Patients
      2. 2.1 Inclusion Criteria
  5. The following inclusion criteria will be monitored:
    1. * 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
    2. * Scanning Option C
      1. 2.2 Exclusion Criteria
  7. The following exclusion criteria will be monitored:
    1. * Patient 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
      1. 3.0 Eligibility Criteria for Healthy Controls
      2. 3.1 Inclusion Criteria
  9. The following inclusion criteria will be monitored:
    1. * 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
    2. * Scanning Option A OR * Scanning Option B
      1. 3.2 Exclusion Criteria
  11. The following exclusion criteria will be monitored:
    1. * 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
      1. 4.0 Eligibility Criteria for COVID-19 patients
      2. 4.1 Inclusion Criteria
  13. The following inclusion criteria will be monitored:
    1. * Patient is \>/= 18 years old* Patient is capable of making an informed decision regarding his/her treatment* Patient with a history of SARS-CoV-2 (active or recovered) infection, based on positive RT-PCR testing* Recovered COVID-19 patient must show evidence of being non-infectious (per Stanford guideline):
    2. * Symptomatic, non-immunocompromised outpatients are considered COVID neg after 10 days or 3 days after symptoms resolve, whichever is longer. * Severely symptomatic or is immunocompromised outpatients are considered non-infectious after 20 days. * or RT-PCR negative x2, spaced \>24 hrs apart* Patient shows or has shown evidence of pulmonary opacities as visualized on chest radiograph or CT* Patient is able to comply with study procedures and infection control instructions
    3. * Recovered COVID 19 patients: Scanning Option A OR * Recovered COVID-19 patients: Scanning Option B * COVID-19 patients with active infection or no evidence of non-active infection: Scanning Option D
      1. 4.2 Exclusion Criteria
  15. The following exclusion criteria will be monitored:
    1. * Person with serious uncontrolled concurrent medical illness, such as severe hypoxia, that would limit compliance with study and infection control requirements* Person with pre-existing fibrosing lung disease (such as but not limited to IPF, NSIP, HP, and sarcoidosis prior to COVID-19 infection).* Person is pregnant or lactating
Exclusion Criteria:
  1. The following exclusion criteria will be monitored:
    1. * Patient 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
      1. 2.0 Eligibility Criteria for PSC Patients
      2. 2.1 Inclusion Criteria
  3. The following inclusion criteria will be monitored:
    1. * 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
    2. * Scanning Option C
      1. 2.2 Exclusion Criteria
  5. The following exclusion criteria will be monitored:
    1. * Patient 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
      1. 3.0 Eligibility Criteria for Healthy Controls
      2. 3.1 Inclusion Criteria
  7. The following inclusion criteria will be monitored:
    1. * 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
    2. * Scanning Option A OR * Scanning Option B
      1. 3.2 Exclusion Criteria
  9. The following exclusion criteria will be monitored:
    1. * 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
      1. 4.0 Eligibility Criteria for COVID-19 patients
      2. 4.1 Inclusion Criteria
  11. The following inclusion criteria will be monitored:
    1. * Patient is \>/= 18 years old* Patient is capable of making an informed decision regarding his/her treatment* Patient with a history of SARS-CoV-2 (active or recovered) infection, based on positive RT-PCR testing* Recovered COVID-19 patient must show evidence of being non-infectious (per Stanford guideline):
    2. * Symptomatic, non-immunocompromised outpatients are considered COVID neg after 10 days or 3 days after symptoms resolve, whichever is longer. * Severely symptomatic or is immunocompromised outpatients are considered non-infectious after 20 days. * or RT-PCR negative x2, spaced \>24 hrs apart* Patient shows or has shown evidence of pulmonary opacities as visualized on chest radiograph or CT* Patient is able to comply with study procedures and infection control instructions
    3. * Recovered COVID 19 patients: Scanning Option A OR * Recovered COVID-19 patients: Scanning Option B * COVID-19 patients with active infection or no evidence of non-active infection: Scanning Option D
      1. 4.2 Exclusion Criteria
  13. The following exclusion criteria will be monitored:
    1. * Person with serious uncontrolled concurrent medical illness, such as severe hypoxia, that would limit compliance with study and infection control requirements* Person with pre-existing fibrosing lung disease (such as but not limited to IPF, NSIP, HP, and sarcoidosis prior to COVID-19 infection).* Person is pregnant or lactating
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Investigator(s)

Joshua Mooney
Joshua Mooney
Pulmonologist, Interstitial lung disease specialist, Lung transplant specialist, Heart and lung transplant specialist
Clinical Associate Professor, Medicine - Pulmonary, Allergy & Critical Care Medicine
H. Henry Guo, MD, PhD
H. Henry Guo, MD, PhD
Radiologist
Clinical Professor, Radiology

Contact us to find out if this trial is right for you.

Contact

Andrea Otte, DPT
650-736-4183

View on ClinicalTrials.gov