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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 June 2023
• Main ID: NCT03183570
• Date of registration: 08/05/2017
• Prospective Registration: Yes
• Primary sponsor: Stanford University
• Public title: Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT
• Scientific 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
• Date of first enrolment: November 8, 2017
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03183570
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Andrea Otte, DPT

• Name: Andrea Otte, DPT

• Name: Henry Guo, MD, PhD
• Affiliation: Stanford University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Covid19 Pneumonia

Primary Sclerosing Cholangitis

Idiopathic Pulmonary Fibrosis

Intervention(s)

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

Primary Outcome(s)

SUV max comparison : IPF versus Healthy Lung, PSC versus Healthy Liver, COVID19 versus Healthy Lung [Time Frame: an estimated average of 2 hours]

Secondary Outcome(s)

Incidence of Study Completion (Safety and Tolerability) [Time Frame: an estimated average of 2 hours]

Time Activity Measurements [Time Frame: an estimated average of 1 hours]

Secondary ID(s)

IRB Protocol: 40450

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pliant Therapeutics, Inc.