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Radiopharmaceutical

[68Ga]CBP8 PET Imaging for Idiopathic Pulmonary Fibrosis

Phase 1

Recruiting

Led By Sydney B Montesi, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Group 2: Lung cancer subjects - Eligible patients will be those harboring locally advanced clinical stage IIIA NSCLC who are deemed candidates for multi-modality therapy, i.e. concurrent chemotherapy and radiation followed by pulmonary resection

Group 3: Subjects with pulmonary fibrosis - IPF (with a UIP or probable UIP pattern); or other forms of interstitial lung disease (ILD), including CTD-ILD, with a fibrotic component as noted by the presence of reticular markings and / or traction bronchiectasis and / or honeycombing on CT

Must not have

Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing

Pneumonia or other acute respiratory illness within 6 weeks of study entry (except for pulmonary fibrosis), pneumonia defined with elevated WBC, fever, infiltrate on CXR and need for antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if a new imaging agent is safe for use in patients with pulmonary fibrosis and if it can help detect collagen deposition.

Who is the study for?

This trial is for healthy adults, lung cancer patients eligible for multi-modality therapy, and those with pulmonary fibrosis aged 40-80. Participants must not have used tobacco recently and should be able to consent. Pregnant individuals, those with certain implants or a high BMI, or recent respiratory infections are excluded.

What is being tested?

[68Ga]CBP8 and PET imaging are being tested to see if they can safely detect collagen in the lungs related to fibrosis. The study includes three groups: healthy individuals, lung cancer patients undergoing specific treatment, and people with pulmonary fibrosis.

What are the potential side effects?

Potential side effects aren't specified but may include reactions typical of PET imaging agents such as discomfort at injection site or allergic reactions. Excessive radiation exposure is also monitored to avoid associated risks.

Eligibility Criteria

Inclusion Criteria

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

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I have stage IIIA NSCLC and am a candidate for combined treatment including surgery.

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I have a type of lung scarring known as pulmonary fibrosis or another similar lung condition.

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I am over 18 and have lung cancer.

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I am between 40 and 80 years old with pulmonary fibrosis.

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I am healthy and have no history of lung diseases.

Exclusion Criteria

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

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I do not have any metal implants, fragments, or metallic tattoos.

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I haven't had pneumonia or a serious lung infection in the last 6 weeks.

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I am not pregnant or breastfeeding, and I have a negative pregnancy test.

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I cannot lie comfortably in an MR-PET machine.

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I experience severe discomfort in confined spaces.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ability to detect increased collagen deposition in pulmonary fibrosis.

Secondary study objectives

Ability of the degree of collagen deposition to predict disease progression.

Other study objectives

Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.

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: Pulmonary Fibrosis SubjectsExperimental Treatment2 Interventions

Idiopathic pulmonary fibrosis patients or patients with other types of interstitial lung disease with a fibrotic component will receive \[68Ga\]CBP8 and undergo PET imaging.

Group II: Lung Cancer SubjectsExperimental Treatment2 Interventions

Lung cancer patients will receive \[68Ga\]CBP8 and undergo PET imaging.

Group III: Healthy IndividualsExperimental Treatment2 Interventions

Healthy volunteers will receive \[68Ga\]CBP8 and undergo PET imaging.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET Imaging

2008

Completed Phase 3

~370