Trial Search Results

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

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 is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Pliant Therapeutics, Inc.

Intervention(s):

  • Drug: [18F]FP-R01-MG-F2

Phase:

Early Phase 1

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

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