Trial Search Results

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

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Pliant Therapeutics, Inc.

Intervention(s):

  • Drug: [18F]FP-R01-MG-F2

Phase:

Early Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Andrea Otte, DPT
650-736-4183
Recruiting