[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06532071":3,"trial-entities:NCT06532071":102,"trial-summary:NCT06532071":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":40,"secondary_outcomes":45,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":14,"eligibility_criteria":57,"std_ages":61,"locations":64,"central_contacts":83,"overall_officials":88,"references":90,"see_also_links":101},"NCT06532071","2024P001746","Advanced Imaging for Pulmonary Fibrosis","RECRUITING","2028-12-31","2026-04","2026-04-22","2025-01-21","Peter Caravan","OTHER",false,"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.",[18],"Pulmonary Fibrosis",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"PHASE2",{"count":25,"type":26},60,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","[68Ga]CBP8","Participants will receive a single intravenous injection of up to 350 MBq of \\[68Ga\\]CBP8",[33],"Participants with Pulmonary Fibrosis",{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Gadoterate Meglumine","Participants will receive a single intravenous injection of 0.05 mmol\u002Fkg gadoterate meglumine during DCE-MRI",[33],[39],"Dotarem",[41],{"measure":42,"description":43,"timeFrame":44},"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",[46,49,51],{"measure":47,"description":48,"timeFrame":44},"Decline of forced vital capacity (FVC) ≥ 5% from baseline","FVC will be measured at baseline, 6, 12, 18, and 24 months",{"measure":50,"description":48,"timeFrame":44},"Decline of forced vital capacity (FVC) ≥10% from baseline",{"measure":52,"description":53,"timeFrame":44},"Decline of diffusing capacity for carbon monoxide (DLCO) ≥15% from baseline","DLCO will be measured at baseline, 6, 12, 18, and 24 months","ALL","18 Years","80 Years",{"inclusion":58,"exclusion":59,"raw_text":60},[],[],"Inclusion Criteria:\n\n1. 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.\n2. On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, mycophenolate sodium, and\u002For rituximab) for at least 3 months.\n3. Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.\n4. FVC of \\>\u002F= 45% and DLCO \\>\u002F= 25% predicted on PFTs performed at Visit 1.\n\nExclusion Criteria:\n\n1. Current or prior exposure to FDA approved anti-fibrotic therapy.\n2. Extent of emphysema greater than extent of fibrosis.\n3. Pregnancy or plans to become pregnant at baseline or during follow-up.\n4. Contraindications to MRI.\n5. Contraindications to receiving gadolinium-based contrast agents.\n6. Research-related radiation exposure exceeds 50 mSv in the prior year.\n7. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin (only for individuals with a history of chronic kidney disease).\n8. Clinically significant PH defined by use of pulmonary vasodilatory therapy.\n9. Respiratory infection within the prior 6 weeks.\n10. Smoking of any kind within the prior 6 months.",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"status":7,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":80},"Massachusetts General Hospital","Boston","Massachusetts","02114","United States",[72,77],{"name":73,"role":74,"phone":75,"email":76},"Caroline Fromson","CONTACT","617 643 3260","cfromson@mgh.harvard.edu",{"name":78,"role":79},"Sydney Montesi, MD","PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},42.35843,-71.05977,[84,87],{"name":78,"role":74,"phone":85,"email":86},"617 724 4030","sbmontesi@mgb.org",{"name":73,"role":74,"phone":75,"email":76},[89],{"name":78,"affiliation":66,"role":79},[91,95,98],{"pmid":92,"type":93,"citation":94},"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\u002Fjnumed.122.264530. Epub 2022 Dec 8.",{"pmid":96,"type":93,"citation":97},"31161770","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\u002Frccm.201903-0503LE. No abstract available.",{"pmid":99,"type":93,"citation":100},"28381537","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\u002Fscitranslmed.aaf4696.",[],{"nct_id":4,"conditions":103,"biomarkers":107},[104,105,18,106],"Extrinsic Allergic Alveolitis","Interstitial lung disease due to connective tissue disease","Undifferentiated Interstitial Lung Disease",[],{"nct_id":4,"found":109,"summary":110,"prompt_version":119},true,{"design":111,"status":112,"heading":6,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This interventional study plans to enroll 60 participants. It is not specified if it is randomized or blinded.","completed","This study is looking at new ways to predict how pulmonary fibrosis (scarring of the lungs) will progress in people with certain types of interstitial lung disease (ILD). Researchers are testing two imaging techniques: a PET scan using [68Ga]CBP8 and an MRI using Gadoterate Meglumine. They want to see if these scans can help identify who will experience worsening lung disease over time. You may be able to join if you are between 18 and 80 years old, have chronic hypersensitivity pneumonitis, connective tissue-associated ILD, or undifferentiated ILD, and are on stable immunosuppression treatment. The study aims to enroll 60 participants. The study's success will be measured by how well these imaging methods predict the development of progressive pulmonary fibrosis over 24 months.","Participants will be followed for up to 24 months to assess the development of progressive pulmonary fibrosis.",123,"Participants will receive a single intravenous injection of [68Ga]CBP8 and a single intravenous injection of Gadoterate Meglumine. They will undergo combined PET and MRI scans at the beginning of the study.","Not stated in the trial record.",[30,35],"v2"]