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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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The goal of this study is to investigate the ability of [68Ga]CBP8 to detect collagen deposition in early interstitial lung disease.
[68Ga]CBP8, is a PET imaging probe which selectively binds collagen type I. Collagen deposition is a pivotal event in the development of pulmonary fibrosis. [68Ga]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles. [68Ga]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis and response to treatment. In addition, [68Ga]CBP8 can detect increased collagen in the lungs of patients with idiopathic pulmonary fibrosis.
The goals of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) | Experimental | Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive [68Ga]CBP8 and undergo PET-MRI. |
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| First degree relatives of a family member with pulmonary fibrosis | Experimental | First degree relatives of a family member with pulmonary fibrosis will receive [68Ga]CBP8 and undergo PET-MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]CBP8 | Drug | An injection of up to 350 MBq of [68Ga]CBP8 will be administered intravenously followed by PET-MRI. |
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of uptake of [68Ga]CBP8 | The degree of uptake of [68Ga]CBP8 in the lungs will be compared between groups and associations with disease severity and progression will be determined. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of MRI contrast clearance, Kwashout, in the lungs | Kwashout rates will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined. | 24 months |
| Rate of MRI contrast arrival, Kwashin, in the lungs |
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Inclusion Criteria:
Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8)
Group 2: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) (n=22)
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sydney B Montesi, MD | Contact | 617-724-4030 | sbmontesi@partners.org | |
| Abimbola Akinniyi | Contact | 781-513-0207 | aakinniyi@mgb.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31161770 | Background | 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 |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
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| Dotarem | Drug | Dotarem will be administered during MRI portion of study. |
|
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Kwashin rates will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined. |
| 24 months |
| Peak enhancement of MRI contrast in the lungs | Peak enhancement will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined. | 24 months |
| 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. |