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Collagen-targeted PET Imaging for Interstitial Lung Disease

Phase 2
Recruiting
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: Age greater than 40 years
Group 1: No known history of interstitial lung disease
Must not have
Parenchymal lung disease except for ILD/ILAs or emphysema
Prior radiation therapy to the thorax
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions

Summary

This trial will study if a new 68Ga-labeled peptide can help detect early stages of interstitial lung disease.

Who is the study for?
This trial is for people over 40 years old with early signs of interstitial lung disease (ILD) or those without ILD but have a relative with pulmonary fibrosis. Participants should not have used tobacco in the last 6 months, be pregnant, or have certain metal implants and allergies to gadolinium. They must also be able to lie comfortably in an MR-PET scanner.
What is being tested?
The study tests [68Ga]CBP8's ability to detect collagen in lungs affected by early ILD using PET imaging. It compares this new method against Dotarem, a standard contrast agent, to see which better identifies early disease stages.
What are the potential side effects?
Potential side effects may include allergic reactions to the contrast agents used ([68Ga]CBP8 or Dotarem), discomfort from lying still during scanning, and exposure to radiation during PET imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 40 years old.
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I have never had interstitial lung disease.
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My lung condition shows early signs of scarring but not a specific severe pattern.
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I have a close family member with pulmonary fibrosis.
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I am over 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a lung condition that is not ILD/ILAs or emphysema.
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I have had radiation therapy to my chest area before.
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I had a minimally invasive chest surgery within the last 6 months.
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I experience severe discomfort in confined spaces.
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My kidney function is low, with an eGFR under 30.
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I cannot lie comfortably in an MR-PET machine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Degree of uptake of [68Ga]CBP8
Secondary study objectives
Peak enhancement of MRI contrast in the lungs
Rate of MRI contrast arrival, Kwashin, in the lungs
Rate of MRI contrast clearance, Kwashout, in the lungs

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)Experimental Treatment2 Interventions
Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive \[68Ga\]CBP8 and undergo PET-MRI.
Group II: First degree relatives of a family member with pulmonary fibrosisExperimental Treatment2 Interventions
First degree relatives of a family member with pulmonary fibrosis will receive \[68Ga\]CBP8 and undergo PET-MRI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadoteric acid
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,010 Previous Clinical Trials
13,308,990 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,549 Previous Clinical Trials
14,401,286 Total Patients Enrolled

Media Library

[68Ga]CBP8 Clinical Trial Eligibility Overview. Trial Name: NCT05417776 — Phase 2
Interstitial Lung Disease Research Study Groups: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD), First degree relatives of a family member with pulmonary fibrosis
Interstitial Lung Disease Clinical Trial 2023: [68Ga]CBP8 Highlights & Side Effects. Trial Name: NCT05417776 — Phase 2
[68Ga]CBP8 2023 Treatment Timeline for Medical Study. Trial Name: NCT05417776 — Phase 2
~4 spots leftby Apr 2025
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