Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis and Primary Sclerosing Cholangitis Using PET/CT

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

1. Eligibility Criteria for IPF Patients 1.1 Inclusion Criteria

  • - 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 (60 +20 +20 mins) OR - Scanning Option B (8 +8 mins) 1.2 Exclusion Criteria - Patients 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.
Eligibility Criteria for PSC Patients 2.1

Inclusion Criteria:

  • - 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 o Scanning Option C (8 +8 mins) 2.2

    Exclusion Criteria:

    - Patients 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.
Eligibility Criteria for Healthy Control 3.1

Inclusion Criteria:

- 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 (60 + 20 + 20 mins) OR - Scanning Option B (8 + 8 mins) 3.2

Exclusion Criteria:

- 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03183570
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Stanford University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Henry Guo, MD, PhD
Principal Investigator Affiliation Stanford University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis
Additional Details

Stanford University has developed a new PET tracer that selectively binds to integrin avb6, a cell surface receptor that is overexpressed in idiopathic pulmonary fibrosis (IPF). Increased avb6 receptors on IPF lung tissue has been well documented, while its expression remains relatively non-existent in the healthy adult lung. In primary sclerosing cholangitis (PSC), integrin avb6 is also up-regulated in the biliary epithelial cells, which drive the progression of biliary tree strictures and liver fibrosis through activation of TGF-b, as has been shown in IPF. The selected PET tracer [18F]FP-R01-MG-F2 has shown promise identifying integrin avb6 in both preclinical and clinical studies at Stanford University. The investigators have demonstrated low [18F]FP-R01-MG-F2 radiopharmaceutical uptake in the heart and lung region of healthy volunteers, which was an expected biodistribution (the normal tissue uptake of the radiopharmaceutical within the body) based on immunohistochemical staining of healthy lung tissue, which demonstrated the presence of minimal avb6 receptors in healthy lung tissue. Similarily, radiopharmaceutical uptake in the hepatic and biliary region of healthy volunteers was low, suggesting that it may also be useful for the detection of increased avb6 in the bile ducts of cholestatic liver disease patients such as PSC. OBJECTIVE: 1) To evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in patients with Idiopathic Pulmonary Fibrosis and Primary Sclerosing Cholangitis We will evaluate [18F]FP-R01-MG-F2 for the detection of Idiopathic Pulmonary Fibrosis (IPF) and Primary Sclerosing Cholangitis (PSC). The performance of [18F]FP-R01-MG-F2 PET/CT will be assessed in a cohort of up to 13-15 IPF patients, 5 PSC patients, and 5 age-matched healthy controls. Feasibility will be measured by drawing regions of interest (ROI) around the lung/ liver of participants with IPF or PSC, respectively, and the lungs of healthy adult volunteers and comparing the calculated standardized uptake value maximum(s) (SUVmax). The tracer's biodistribution, safety, and tolerability will also be studied.

Arms & Interventions

Arms

Experimental: [18F]FP-R01-MG-F2 PET/CT

7mCi (range 6-9 mCi) [18F]FP-R01-MG-F2 will be administered to all study participants. IPF patients and healthy volunteers will have a 60-minute dynamic PET/CT scan to the center of the lungs in the FOV followed by two vertex-to-thigh PET/CT scans. PSC patients will have only two vertex-to-thigh PET/CT scans to the center of the liver in the FOV. 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).

Interventions

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

7mCi (range 6-9mCi) [18F]FP-R01-MG-F2 will be administered

Contact a Trial Team

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Stanford University, Stanford, California

Status

Recruiting

Address

Stanford University

Stanford, California, 94305

Site Contact

Andrea Otte, DPT

anotte@stanford.edu

650-736-4183

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