Clinical Drug Experience Knowledgebase

Criteria

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