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New treatment option for Pulmonary Fibrosis
Official title Advanced Imaging for Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT06532071
What this study is testing
What is [68Ga]CBP8?
[68Ga]CBP8 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine if measurements of active collagen deposition using [68Ga]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict an individual patient's pace of disease progression in non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) and identify which individuals will develop progressive pulmonary fibrosis.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD (due to rheumatoid arthritis, systemic...
- On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, mycophenolate sodium, and/or rituximab) for at least 3 months.
- Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.
- FVC of \>/= 45% and DLCO \>/= 25% predicted on PFTs performed at Visit 1.
You likely can't join if
- Current or prior exposure to FDA approved anti-fibrotic therapy.
- Extent of emphysema greater than extent of fibrosis.
- Pregnancy or plans to become pregnant at baseline or during follow-up.
- Contraindications to MRI.
- Contraindications to receiving gadolinium-based contrast agents.
- Research-related radiation exposure exceeds 50 mSv in the prior year.
See the full eligibility criteria
- Age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD (due to rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease), or undifferentiated ILD.
- On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, mycophenolate sodium, and/or rituximab) for at least 3 months.
- Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.
- FVC of \>/= 45% and DLCO \>/= 25% predicted on PFTs performed at Visit 1.
- Current or prior exposure to FDA approved anti-fibrotic therapy.
- Extent of emphysema greater than extent of fibrosis.
- Pregnancy or plans to become pregnant at baseline or during follow-up.
- Contraindications to MRI.
- Contraindications to receiving gadolinium-based contrast agents.
- Research-related radiation exposure exceeds 50 mSv in the prior year.
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min (only for individuals with a history of chronic kidney disease).
- Clinically significant PH defined by use of pulmonary vasodilatory therapy.
- Respiratory infection within the prior 6 weeks.
- Smoking of any kind within the prior 6 months.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.