Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL171240 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate how immunosuppression treatment affects measurements of active collagen deposition using [68Ga]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in individuals with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD).
15 different subjects with non-IPF ILD starting immunosuppression treatment for their underlying ILD will be enrolled. Participants will undergo [68Ga]CBP8 PET and DCE-MRI prior to and 12 weeks after treatment initiation to determine the effects of immunosuppressive treatment on PET measurements of collagen deposition and selected DCE-MRI-derived measurements.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 prior to and 12 weeks after starting clinically-prescribed immunosuppression for treatment of non-IPF ILD |
|
| 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 |
|---|---|---|
| Change in SUVmax25 over the entire lungs | Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the mean of the upper quartile of standardized uptake values (SUVmax25). Primary [68Ga]CBP8-PET outcome. | From baseline to 12 weeks |
| Change in the rate of contrast washin (kwashin) over the entire lungs | Changes in rate of contrast washin will be measured using dynamic-contrast enhanced MRI. Primary DCE-MRI outcomes. | From baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SUVmean over the entire lungs | Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the mean standardized uptake value (SUVmean). | From baseline to 12 weeks |
| Change in SUVmax over the entire lungs |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| 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 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gadoterate Meglumine | Drug | Participants will receive a single intravenous injection of 0.05 mmol/kg gadoterate meglumine during DCE-MRI |
|
Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the max standardized uptake value (SUVmax). |
| From baseline to 12 weeks |
| Change in peak enhancement over the entire lungs | Changes in peak enhancement will be measured using dynamic-contrast enhanced MRI | From baseline to 12 weeks |
| Change in time to peak over the entire lungs | Changes in time to peak will be measured using dynamic-contrast enhanced MRI | From baseline to 12 weeks |
| Change in the area under the curve at 60 seconds (AUC60) over the entire lungs | Changes in the area under the curve at 60 seconds will be measured using dynamic-contrast enhanced MRI | From baseline to 12 weeks |
| Change in the rate of contrast washout (kwashout) over the entire lungs | Changes in the rate of contrast washout will be measured using dynamic-contrast enhanced MRI. | From baseline to 12 weeks |
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |