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PET/CT Scan with [18F]FP-R01-MG-F2 for Pulmonary Fibrosis

Q: Does this clinical research currently have any open spots to enroll in?

<p>Affirmative. Evidence on clinicaltrials.gov reveals that this trial is now recruiting, with the first posting of the study taking place on November 8th 2017 and an update being made as recently as May 3rd 2022. 30 patients are expected to take part across 1 facility.</p>

Q: What is the current recruitment size for this experiment?

<p>Affirmative. The listing on clinicaltrials.gov attests to this research initiative's current recruitment of patients, which commenced on November 8th 2017 and was most recently revised on May 3rd 2022. 30 participants are planned to be enrolled at one particular medical site.</p>

Phase < 1

Recruiting

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 diagnosed with IPF by a pulmonologist according to ATS guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an estimated average of 2 hours

Awards & highlights

Study Summary

This trial looked at using a new PET scan to detect three different diseases: idiopathic pulmonary fibrosis, primary sclerosing cholangitis, and coronavirus disease 2019.

Who is the study for?

This trial is for adults diagnosed with Idiopathic Pulmonary Fibrosis (IPF) or Primary Sclerosing Cholangitis (PSC), and those who have had COVID-19. Participants must be able to make informed decisions, follow study procedures, and meet specific health criteria like lung function tests. Pregnant individuals, those with certain other medical conditions or a recent history of cancer are excluded.Check my eligibility

What is being tested?

[18F]FP-R01-MG-F2 is being tested using PET/CT scans to detect Integrin avb6 in patients with IPF, PSC, or COVID-19. The study aims to understand how this imaging agent can help visualize disease processes in these conditions.See study design

What are the potential side effects?

The potential side effects are not explicitly listed for [18F]FP-R01-MG-F2; however, as it involves PET/CT scanning, there may be exposure to radiation and possible allergic reactions to the tracer used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with large duct PSC based on specific liver tests.

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I have been diagnosed with IPF by a lung specialist.

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My chest X-ray or CT scan shows shadowy areas in my lungs.

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I am 18 years old or older.

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I have had COVID-19, confirmed by a PCR test.

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I am 45 years old or older.

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My CT scan shows a specific lung disease pattern.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ an estimated average of 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~an estimated average of 2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and an estimated average of 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Incidence of Study Completion (Safety and Tolerability)

Time Activity Measurements

Trial Design

3Treatment groups

Experimental Treatment

Group I: [18F]FP-R01-MG-F2 PET/CT in actively infected COVID19 PatientsExperimental Treatment1 Intervention

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.

Group II: [18F]FP-R01-MG-F2 PET/CT in PSC PatientsExperimental Treatment1 Intervention

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.

Group III: [18F]FP-R01-MG-F2 PET/CT in IPF Patients, Recovered COVID19 Patients, and Healthy VolunteersExperimental Treatment1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[18F]FP-R01-MG-F2

2016

Completed Early Phase 1

~30

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pliant Therapeutics, Inc.Industry Sponsor

7 Previous Clinical Trials

703 Total Patients Enrolled

4 Trials studying Idiopathic Pulmonary Fibrosis

499 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,565 Total Patients Enrolled

4 Trials studying Idiopathic Pulmonary Fibrosis

69 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Henry Guo, MD, PhD5.01 ReviewsStudy Director - Stanford University

Stanford University

Media Library

[18F]FP-R01-MG-F2 Clinical Trial Eligibility Overview. Trial Name: NCT03183570 — Phase < 1

Idiopathic Pulmonary Fibrosis Research Study Groups: [18F]FP-R01-MG-F2 PET/CT in actively infected COVID19 Patients, [18F]FP-R01-MG-F2 PET/CT in PSC Patients, [18F]FP-R01-MG-F2 PET/CT in IPF Patients, Recovered COVID19 Patients, and Healthy Volunteers

Idiopathic Pulmonary Fibrosis Clinical Trial 2023: [18F]FP-R01-MG-F2 Highlights & Side Effects. Trial Name: NCT03183570 — Phase < 1

[18F]FP-R01-MG-F2 2023 Treatment Timeline for Medical Study. Trial Name: NCT03183570 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research currently have any open spots to enroll in?

"Affirmative. Evidence on clinicaltrials.gov reveals that this trial is now recruiting, with the first posting of the study taking place on November 8th 2017 and an update being made as recently as May 3rd 2022. 30 patients are expected to take part across 1 facility."

Answered by AI

What is the current recruitment size for this experiment?

"Affirmative. The listing on clinicaltrials.gov attests to this research initiative's current recruitment of patients, which commenced on November 8th 2017 and was most recently revised on May 3rd 2022. 30 participants are planned to be enrolled at one particular medical site."

Answered by AI

Recent research and studies

Nature CommunicationsJournal

Evaluation of Integrin Αvβ6 Cystine Knot PET Tracers to Detect Cancer and Idiopathic Pulmonary Fibrosis

Kimura, Richard H., Ling Wang, Bin Shen, Li Huo, Willemieke Tummers, Fabian V. Filipp, Haiwei Henry Guo, et al.. 2019. “Evaluation of Integrin Αvβ6 Cystine Knot PET Tracers to Detect Cancer and Idiopathic Pulmonary Fibrosis”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/s41467-019-11863-w.

clinicaltrials.govStudy

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

Haiwei Henry Guo 2017. "Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03183570.

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