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

• Status: Recruiting
• Trial end date: 2023-04-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stanford University
• Collaborators: Pliant Therapeutics; Pliant Therapeutics, Inc.

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