Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-02 @ 12:46 PM
Study NCT ID:
NCT06467968
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2024-06-18', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between the captation of radiotracer and the cardiovascular disease', 'timeFrame': '1 day', 'description': 'Measurement of myocardial activity'}], 'secondaryOutcomes': [{'measure': 'Relationship between the captation of radiotracer and the troponin value', 'timeFrame': '1 day', 'description': 'Correlation between the myocardial activity and the troponin value'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Inflammation']}, 'descriptionModule': {'briefSummary': 'Gallium-68-DOTATOC binds primarily with high affinity to somatostatin subtype 2 (SSTR2) receptors and these somatostatin receptors are also overexpressed on inflammation cells when activated.\n\nThe hypothesis is that the GATED mode on a Gallium-68-DOTATOC cardiac recording would be able to highlight abnormalities that could be correlated with the age of the patients and their cardiovascular risk factors.', 'detailedDescription': 'People with the selection criteria for the study, coming to the nuclear medicine department in order to benefit from a Gallium-68-DOTATOC PET/CT exam as part of a diagnostic or pre-therapeutic assessment of a neuroendocrine tumor will be offer to participate in the study After sign consent, patients were install in a room to have blood drawn for Troponin Ic, BNP and CRP and after Gallium-68-DOTATOC infusion Gallium-68-DOTATOC PET/CT will be recorded and immediately the cardiac record in Gated mode'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPersons who have received complete information on the organization of the research and who have signed the informed consent and:\n\n* Age ≥ 18 years old.\n* Having read and understood the information document.\n* Affiliated to a social security scheme.\n\nPerson for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumour.\n\nExclusion Criteria:\n\nPerson with\n\n* Hypersensitivity during previous use of 68Ga-DOTATOC\n* Impossibility of performing a PET-CT (patient agitated, confused, etc.).\n* History of heart disease,\n* Severe arrhythmia that does not allow the PET synchronized with the ECG\n* Severe renal insufficiency (GFR \\<30 ml/min/1.73 m2)\n* Treated with a somatostatin analogue.\n* Cushing's syndrome\n* Pregnant woman, likely to be or breastfeeding\n* Adult subject to a legal protection measure (guardianship, curators, legal safeguard)\n* Person of legal age unable to express their consent\n* Person deprived of liberty by a judicial or administrative decision\n* Person, subject to psychiatric care under articles L. 3212-1 and L. 3213-1"}, 'identificationModule': {'nctId': 'NCT06467968', 'acronym': 'GATEDOTA', 'briefTitle': 'Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'GATED-PET Heart Analysis in Patients Having a Gallium-68--DOTATOC PET/CT Exam for Oncology Indication', 'orgStudyIdInfo': {'id': '2022PI008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': 'Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumor', 'interventionNames': ['Other: Cardiac ECG-gated PET imaging will added']}], 'interventions': [{'name': 'Cardiac ECG-gated PET imaging will added', 'type': 'OTHER', 'otherNames': ['blood sample'], 'description': 'Blood sample will be used to measure troponin, BNP and CRP . After 68Ga-DOTATOC PET/CT whole body recording, a cardiac ECG-gated PET imaging will added', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'VERONIQUE ROCH', 'role': 'CONTACT', 'email': 'v.roch@chru-nancy.fr'}], 'facility': 'Veronique Roch', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'VERONIQUE ROCH, MSc', 'role': 'CONTACT', 'email': 'v.roch@chru-nancy.fr', 'phone': '03 83 15 42 76', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Mathieu PERRIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mathieu PERRIN', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}