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

Recruiting

I'm Interested

Trial ID: NCT03183570

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

Stanford Investigator(s)

Aparna Goel

Clinical Associate Professor, Medicine - Gastroenterology & Hepatology

H. Henry Guo, MD, PhD
H. Henry Guo, MD, PhD

Clinical Professor, Radiology

Aruna Subramanian
Aruna Subramanian

Clinical Professor, Medicine - Infectious Diseases

Joshua Mooney
Joshua Mooney

Clinical Assistant Professor, Medicine - Pulmonary, Allergy & Critical Care Medicine

Tushar Desai
Tushar Desai

Professor of Medicine (Pulmonary, Allergy and Critical Care Medicine)

Benjamin Lewis Franc
Benjamin Lewis Franc

Clinical Professor, Radiology - Rad/Nuclear Medicine

Farshad Moradi
Farshad Moradi

Clinical Associate Professor, Radiology - Rad/Nuclear Medicine

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology

Andrei Iagaru
Andrei Iagaru

Professor of Radiology (Nuclear Medicine)

Eligibility


1.0 Eligibility Criteria for IPF Patients

1.1 Inclusion Criteria

The following inclusion criteria will be monitored:

   - 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 OR

      - Scanning Option B

1.2 Exclusion Criteria

The following exclusion criteria will be monitored:

   - 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

2.0 Eligibility Criteria for PSC Patients

2.1 Inclusion Criteria

The following inclusion criteria will be monitored:

   - 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

      - Scanning Option C

2.2 Exclusion Criteria

The following exclusion criteria will be monitored:

   - 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

3.0 Eligibility Criteria for Healthy Controls

3.1 Inclusion Criteria

The following inclusion criteria will be monitored:

   - 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 OR

      - Scanning Option B

3.2 Exclusion Criteria

The following exclusion criteria will be monitored:

   - 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

4.0 Eligibility Criteria for COVID-19 patients

4.1 Inclusion Criteria

The following inclusion criteria will be monitored:

   - 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):

      - 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

      - 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

4.2 Exclusion Criteria

The following exclusion criteria will be monitored:

   - 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

Intervention(s):

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

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Andrea Otte, DPT
650-736-4183