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

NCT03183570 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB Protocol: 40450
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Idiopathic Pulmonary Fibrosis; Primary Sclerosing Cholangitis; Covid19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• SUV max comparison : IPF versus Healthy Lung, PSC versus Healthy Liver, COVID19 versus Healthy Lung

  The SUVmax in a lung or liver with known IPF, COVID19 pneumonia, or PSC respectively will be compared to the SUVmax in a known healthy lung/liver. It is expected that the SUV max, which is a measurement of the maximum value of radiopharmaceutical uptake within the region of interest (ROI) in IPF, COVID19 pneumonia, and PSC will be higher than the SUV max in the healthy lung/liver.

  an estimated average of 2 hours

Secondary Outcomes (2)

• Time Activity Measurements

  an estimated average of 1 hours

• Incidence of Study Completion (Safety and Tolerability)

  an estimated average of 2 hours

Study Arms (3)

[18F]FP-R01-MG-F2 PET/CT in IPF Patients, Recovered COVID19 Patients, and Healthy Volunteers

EXPERIMENTAL

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).

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

[18F]FP-R01-MG-F2 PET/CT in PSC Patients

EXPERIMENTAL

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.

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

[18F]FP-R01-MG-F2 PET/CT in actively infected COVID19 Patients

EXPERIMENTAL

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.

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

Interventions

[18F]FP-R01-MG-F2 DRUG

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

[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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Eligibility Criteria for PSC Patients
• 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
• 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

Sponsors & Collaborators

• Stanford University: lead
• Pliant Therapeutics, Inc.: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• Kimura RH, Wang L, Shen B, Huo L, Tummers W, Filipp FV, Guo HH, Haywood T, Abou-Elkacem L, Baratto L, Habte F, Devulapally R, Witney TH, Cheng Y, Tikole S, Chakraborti S, Nix J, Bonagura CA, Hatami N, Mooney JJ, Desai T, Turner S, Gaster RS, Otte A, Visser BC, Poultsides GA, Norton J, Park W, Stolowitz M, Lau K, Yang E, Natarajan A, Ilovich O, Srinivas S, Srinivasan A, Paulmurugan R, Willmann J, Chin FT, Cheng Z, Iagaru A, Li F, Gambhir SS. Evaluation of integrin alphavbeta6 cystine knot PET tracers to detect cancer and idiopathic pulmonary fibrosis. Nat Commun. 2019 Oct 14;10(1):4673. doi: 10.1038/s41467-019-11863-w.

  PMID: 31611594 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Henry Guo, MD, PhD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: June 12, 2017
• Study Start: November 8, 2017
• Primary Completion: April 25, 2023
• Study Completion: January 25, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)