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Idiopathic Pulmonary FibrosisEarly Phase 1NCT03183570

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

A Early Phase 1 study testing [18F]FP-R01-MG-F2 in people with Idiopathic Pulmonary Fibrosis and Primary Sclerosing Cholangitis, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
[18F]FP-R01-MG-F2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
8 Nov 2017to 25 Jan 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official 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

Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 with [18F]FP-R01-MG-F2 with PET/CT

Read the detailed description

Stanford University has developed a new PET tracer, [18F]FP-R01-MG-F2, 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.

The PET tracer's application will be expanded in primary sclerosing cholangitis (PSC) and COVID-19 pneumonia. The 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 shown in IPF. Similarly, COVID-19 pneumonia is caused by the SARS-CoV-2 and leads to acute lung injury and integrin avb6 up-regulation.

The selected PET tracer [18F]FP-R01-MG-F2 has shown promise in 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.

OBJECTIVE:

  1. Exploring the use of the investigational radiopharmaceutical [18]FFP-R01-MG-F2 as a biomarker for avb6 integrin in fibrotic lung tissue.
  2. Exploring the use of the investigational radiopharmaceutical [18]FFP-R01-MG-F2 to access inflammation and fibrosis in the bile duct and liver.
  3. Exploring the use of the investigational radiopharmaceutical [18]FFP-R01-MG-F2 to assess lung injury in COVID-19 pneumonia.

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, 5 COVID19 pneumonia 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, COVID19, or PSC, respectively, and the lungs of healthy adult volunteers and comparing the calculated standardized uptake value maximum(s) (SUV max).

The tracer's biodistribution, safety, and tolerability will also be studied.

Recruitment of IPF subjects and healthy volunteers has been completed, although recruitment for other aspects of this clinical trial is ongoing.

Being tested
[18F]FP-R01-MG-F2
Medical subject headings
Idiopathic Pulmonary Fibrosis, Cholangitis, Sclerosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]FP-R01-MG-F2Drug

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

Study groups in NCT03183570
Study groupRoleWhat they receive
[18F]FP-R01-MG-F2 PET/CT in IPF Patients, Recovered COVID19 Patients, and Healthy VolunteersExperimentalArm1: 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).
Receives: Drug: [18F]FP-R01-MG-F2
[18F]FP-R01-MG-F2 PET/CT in PSC PatientsExperimentalArm 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.
Receives: Drug: [18F]FP-R01-MG-F2
[18F]FP-R01-MG-F2 PET/CT in actively infected COVID19 PatientsExperimentalArm 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.
Receives: Drug: [18F]FP-R01-MG-F2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: an estimated average of 2 hours

Secondary outcomes (2)
  1. Time Activity Measurements

    Blood samples for blood time-activity measurements taken at 1, 3, 5, 10, 30, and 60 minutes after tracer injection for tracer kinetic analysis. Tracer kinetic analysis shows radiopharmaceutical distribution from the blood to the tissues over time.

    Measured: an estimated average of 1 hours

  2. Incidence of Study Completion (Safety and Tolerability)

    Vital signs and laboratory data collected before IV injection of [18F]FP-R01-MG-F2 and after completion of the scan will allow the investigators to evaluate the safety and tolerability of the radiopharmaceutical. This will be measured as the number of patients who successfully completed the study.

    Measured: an estimated average of 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2017
  2. Study start8 Nov 2017
  3. Primary completion25 Apr 2023
  4. Study completion25 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03183570
Sponsor's protocol ID
IRB Protocol: 40450
Status last verified
Feb 2025
First submitted
8 May 2017
Last updated
4 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31611594

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [18F]FP-R01-MG-F2 in people with Idiopathic Pulmonary Fibrosis and Primary Sclerosing Cholangitis, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SUV max comparison : IPF versus Healthy Lung, PSC versus Healthy Liver, COVID19 versus Healthy Lung (time frame: an estimated average of 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03183570, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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