Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT06131112
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac Sarcoidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tracer uptake - cardiac sarcoidosis and neuroendocrine tumor (negative control)', 'timeFrame': '2 years', 'description': 'The proportion of patients with tracer uptake in the heart on 64Cu-DOTATATE PET/CT in patients with verified cardiac sarcoidosis and the proportion of patients without tracer uptake in the heart on 64Cu-DOTATATE PET/CT for patients with a neuroendocrine tumor without a history of inflammatory heart disease (the control group).'}], 'secondaryOutcomes': [{'measure': '24-month rates of adverse outcomes', 'timeFrame': '2 years', 'description': 'Death, heart failure hospitalizations, decrease of left ventricular ejection fraction to \\<10% and \\<50%, new-onset ventricular tachycardia, new-onset atrioventricular block, implantable cardioverter-defibrillator implantation, shocks from implantable cardioverter-defibrillator, pacemaker implantation, cardiac resyncronization therapy'}, {'measure': 'Tracer uptake - myocarditis', 'timeFrame': '2 years', 'description': 'The proportion of patients with tracer uptake in the heart on 64Cu-DOTATATE PET/CT in patients with verified acute lymphocytic myocarditis'}, {'measure': 'Distribution of tracer uptake', 'timeFrame': '2 years', 'description': 'The distribution of tracer uptake in the heart in patients with cardiac sarcoidosis and acute lymphocytic myocarditis, respectively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Sarcoidosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the CuDOSIS study is to examine the diagnostic value of activated macrophage imaging in patients with or under evaluation for cardiac sarcoidosis. The PET/CT tracer 64Cu-DOTATATE is used as a tool to identify activated macrophages. The trial is an open-label prospective study. The study will include 54 participants from the Department of Cardiology and the Department of Clinical Physiology, Nuclear Medicine, and PET at Rigshospitalet. Further, the study will include data from 22 patients with NET who have been scanned with 64Cu-DOTATATE PET/CT previously as negative controls.\n\nParticipants will be included in the following groups:\n\nGroup A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)', 'detailedDescription': 'Cardiac involvement is considered a serious condition and a frequent cause of death in patients with sarcoidosis. 18F-FDG PET/CT is currently used as part of the diagnostic criteria for cardiac sarcoidosis, but it has shown limitations in the evaluation of cardiac sarcoidosis due to the high physiological uptake of FDG in normal cardiac muscle. Elaborate preparations are required for patients including either a low-carbohydrate diet followed by long fasting or heparin loading before FDG-PET. In heparin loading, the rare adverse effect of heparin-induced thrombocytopenia should be considered. Therefore, it is of interest to find a PET/CT tracer that displays high sensitivity and specificity without requiring thorough patient preparation and minimizing any adverse effects.\n\nA potential tracer is the somatostatin-based tracer 64Cu-DOTATATE, which is routinely used for the diagnosis and monitoring of treatment response in patients with neuroendocrine tumors. Inflammatory cells, including macrophages that are found in sarcoid granulomas, express somatostatin receptors on their surface, whereas normal cardiomyocytes do not. This allows for the potential use of macrophage imaging in cardiac sarcoidosis.\n\nIn the CuDOSIS trial, groups A and B (suspected and confirmed cardiac sarcoidosis, respectively) will be scanned with 64Cu-DOTATATE PET/CT in addition to the routinely performed 18F-FDG PET/CT. Further, to examine whether the macrophage infiltration pattern is different in patients with cardiac sarcoidosis and other inflammatory heart diseases, a group of patients with confirmed or clinically suspected myocarditis will be included (group C); this group will only be scanned with 64Cu-DOTATATE PET/CT. Finally, data from a group of patients with neuroendocrine tumours (negative controls) who have previously been scanned with 64Cu-DOTATATE will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include adults (18 years or older) from the Department of Cardiology and Department of Clinical Physiology, Nuclear Medicine, and PET at Rigshospitalet. The study will include a total of 76 participants: 54 patients from groups A-C and data from 22 patients from group D.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age =\\> 18 years\n* Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)\n\nExclusion Criteria:\n\n* Severe obesity (weight \\> 140 kg)\n* Pregnancy (negative point-of-care urine/serum human chorion gonadotropin is required in all fertile women)\n* Severe claustrophobia\n* Known allergy to 64Cu-DOTATATE\n* Clinically critical condition which makes PET/CT impossible\n* Diabetes with insulin dependence'}, 'identificationModule': {'nctId': 'NCT06131112', 'acronym': 'CuDOSIS', 'briefTitle': 'Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac Sarcoidosis', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Macrophage PET/CT Imaging for the Diagnosis of Cardiac Sarcoidosis', 'orgStudyIdInfo': {'id': 'H-23035676'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': '22 patients with clinically suspected cardiac sarcoidosis', 'interventionNames': ['Diagnostic Test: 64Cu-DOTATATE PET/CT scan']}, {'label': 'Group B', 'description': '22 patients with known cardiac sarcoidosis', 'interventionNames': ['Diagnostic Test: 64Cu-DOTATATE PET/CT scan']}, {'label': 'Group C', 'description': 'Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis', 'interventionNames': ['Diagnostic Test: 64Cu-DOTATATE PET/CT scan']}, {'label': 'Group D', 'description': '22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)'}], 'interventions': [{'name': '64Cu-DOTATATE PET/CT scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients in group A-C will have a 64Cu-DOTATATE PET/CT scan performed in addition to routine clinical procedures. Group D has had 64Cu-DOTATATE PET/CT performed as part of their clinical diagnostic work-up or follow-up; these data are retrospectively identified and included in the study, and group D will not be subject to any scans in the study.', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Finn Gustafsson, MD,PhD,DMSc', 'role': 'CONTACT', 'email': 'finn.gustafsson@regionh.dk', 'phone': '+45 35456340'}, {'name': 'Adelina Yafasova, MD', 'role': 'CONTACT', 'email': 'adelina.henney.yafasova@regionh.dk', 'phone': '+45 35456252'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Finn Gustafsson, MD,PhD,DMSc', 'role': 'CONTACT', 'email': 'finn.gustafsson@regionh.dk', 'phone': '+45 35456340'}, {'name': 'Adelina Yafasova, MD', 'role': 'CONTACT', 'email': 'adelina.henney.yafasova@regionh.dk', 'phone': '+45 35456252'}], 'overallOfficials': [{'name': 'Finn Gustafsson, MD,PhD,DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The overall results of the trial will be made available. Individual participant data (IPD) will not be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Finn Gustafsson', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}