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

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

Must not have

Person had lung infection of any kind in the last 3 months

Person with pre-existing fibrosing lung disease (such as but not limited to IPF, NSIP, HP, and sarcoidosis prior to COVID-19 infection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an estimated average of 2 hours

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a lung infection in the last 3 months.

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I had a lung condition like IPF or sarcoidosis before getting COVID-19.

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I have a history of cancer.

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I have had a lung infection in the past 3 months.

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I have been diagnosed with a lung disease other than IPF by a lung doctor.

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I have been diagnosed with a lung disease other than IPF by a lung doctor.

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I have had a condition where my lymphocytes grow abnormally.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Incidence of Study Completion (Safety and Tolerability)

Time Activity Measurements

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 14Eligibility criteria met