Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT
Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, Covid19 Pneumonia
About this trial
This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis
Eligibility 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
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
[18F]FP-R01-MG-F2 PET/CT in IPF Patients, Recovered COVID19 Patients, and Healthy Volunteers
[18F]FP-R01-MG-F2 PET/CT in PSC Patients
[18F]FP-R01-MG-F2 PET/CT in actively infected COVID19 Patients
Arm1: 7mCi (range 6-9 mCi) [18F]FP-R01-MG-F2 will be administered to the study participant. A 60-minute dynamic PET/CT scan to the center of the lungs in the FOV is followed by two vertex-to-thigh PET/CT scans. NOTE: If the patient cannot tolerate lying down for an extended period of time at the time of imaging, the patient may be switched to scanning protocol Option B, which does not include an initial 60-minute dynamic PET/CT scan. IPF Patients will have a repeat [18F]FP-R01-MG-F2 PET/CT scan performed within 3-8 weeks post initial scan (within 12-24 months post initial scan for previously scanned IPF patients if they are willing to be re-consented).
Arm 2: 7mCi (range 6-9 mCi) [18F]FP-R01-MG-F2 will be administered to the study participant. A 60-minute dynamic PET/CT scan to the center of the liver in the FOV is followed by two vertex-to-thigh PET/CT scans. Patients will have the option for a repeat [18F]FP-R01-MG-F2 PET/CT scan performed within 3-8 weeks post initial scan.
Arm 3: 7mCi (range 6-9 mCi) [18F]FP-R01-MG-F2 will be administered to the study participant. One vertex-to-thigh PET/CT scans to the center of the lung in the FOV will follow approximately 60 min post-injection.