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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.
60 participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) on stable dose immunosuppression treatment will be enrolled. Participants will undergo combined [68Ga]CBP8 positron emission tomography (PET) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at baseline. The investigators will compare the ability of PET and MRI measurements performed over the whole lung and within regions of interest to identify participants who subsequently develop progressive pulmonary fibrosis as determined by changes in pulmonary function testing, quantitative fibrosis on high-resolution computed tomography, and respiratory symptoms over 24 months. The investigators will also test whether combining the PET and MRI measurements results in more accurate prediction of progression than either modality alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Pulmonary Fibrosis | Experimental | Participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) will receive [68Ga]CBP8 and undergo PET combined with dynamic contrast-enhanced MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]CBP8 | Drug | Participants will receive a single intravenous injection of up to 350 MBq of [68Ga]CBP8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of progressive pulmonary fibrosis | Defined by the 2022 ATS guideline definition of progressive pulmonary fibrosis (PPF) which defines PPF as satisfying 2 of 3 criteria within 12 months: worsening symptoms, physiologic progression (absolute decline in FVC ≥ 5% or absolute decline in DLCO ≥ 10%), or radiologic evidence of disease progression. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decline of forced vital capacity (FVC) ≥ 5% from baseline | FVC will be measured at baseline, 6, 12, 18, and 24 months | Up to 24 months |
| Decline of forced vital capacity (FVC) ≥10% from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sydney Montesi, MD | Contact | 617 724 4030 | sbmontesi@mgb.org | |
| Caroline Fromson | Contact | 617 643 3260 | cfromson@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sydney Montesi, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37116909 | Background | Izquierdo-Garcia D, Desogere P, Fur ML, Shuvaev S, Zhou IY, Ramsay I, Lanuti M, Catalano OA, Catana C, Caravan P, Montesi SB. Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8: A Type I Collagen-Targeted PET Probe. J Nucl Med. 2023 May;64(5):775-781. doi: 10.2967/jnumed.122.264530. Epub 2022 Dec 8. | |
| 31161770 | Background |
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
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| Gadoterate Meglumine | Drug | Participants will receive a single intravenous injection of 0.05 mmol/kg gadoterate meglumine during DCE-MRI |
|
|
FVC will be measured at baseline, 6, 12, 18, and 24 months
| Up to 24 months |
| Decline of diffusing capacity for carbon monoxide (DLCO) ≥15% from baseline | DLCO will be measured at baseline, 6, 12, 18, and 24 months | Up to 24 months |
| Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available. |
| 28381537 | Background | Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |