Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2026-01-05 @ 6:33 PM
Study NCT ID:
NCT03232632
Status:
TERMINATED
Last Update Posted:
2020-08-26
First Post:
2017-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}], 'ancestors': [{'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017772', 'term': 'Amyloid Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062942', 'term': "2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole"}, {'id': 'C581552', 'term': 'flutemetamol'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'intervention programming', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-24', 'studyFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ratio Heart/ Upper Mediastinum', 'timeFrame': 'average of last 15 minutes', 'description': 'peak of 18F-Flutemetamol capture'}, {'measure': 'standardized uptake value (SUV) measures', 'timeFrame': 'average of last 15 minutes', 'description': 'standardized uptake value (SUV) measures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Amyloidosis']}, 'descriptionModule': {'briefSummary': "To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.", 'detailedDescription': 'Hypothesis had been performed that PET with 18F-Flutemetamol (Vizamyl®) could lead an early diagnostic. Indeed, this tracer had been recently used to highlight inter-cerebral beta-amyloid plaques on patients with Alzheimer Disease.\n\nBecause this labelling is performed on amyloid deposits, this tracer would lead to view and to quantify amyloid deposits within cardiac amyloid injuries.\n\nResults of this PET will be combined with scan examinations for a better anatomic tracking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients followed for amyloidosis with proved cardiac injury or strongly suspected:\n\n * cardiac echography with typical signs of amyloid injury,\n * anatomical result confirming presence of amyloid deposits at cardiac or peripheral level\n* Signature of Informed Consent Form,\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Patient who suffers from another pathology which could lead cardiac injury (coronary disease, valvular disease, other pathology of deposit),\n* Pregnancy and lactating women,\n* Absence of effective contraception,\n* Irradiating examination performed within the last 12 months or scheduled within the next 12 months,\n* Unable patient physically, mentally or legally to provide informed consent,\n* Patient under a system of legal protection'}, 'identificationModule': {'nctId': 'NCT03232632', 'acronym': 'AMYLCAR', 'briefTitle': 'Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.', 'orgStudyIdInfo': {'id': '13 199 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET with 18 F-Flutemetamol', 'description': "PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication", 'interventionNames': ['Drug: PET with 18 F-Flutemetamol']}], 'interventions': [{'name': 'PET with 18 F-Flutemetamol', 'type': 'DRUG', 'otherNames': ['Vizamyl®'], 'description': 'PET with 18 F-Flutemetamol (Vizamyl ®)', 'armGroupLabels': ['PET with 18 F-Flutemetamol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Eric OUHAYOUN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}