Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT04349358
Status:
RECRUITING
Last Update Posted:
2023-10-17
First Post:
2020-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'C537852', 'term': 'Nuchal bleb, familial'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2030-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2020-04-10', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment', 'timeFrame': 'before maintenance treatment', 'description': 'PET/CT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/CT', 'FDG', 'Fluorocholine (18F) FCH'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Hybrid positron emission tomography/computed tomography (PET/CT) has now become available to detect tumors in patients with multiple myeloma. The radioactive glucose 18F-fluorodeoxyglucose (FDG) is the most widely used tracer but findings suggest that PET/CT reveal more lesions when using FCH.\n\nIn this study, FDG is compared with a more recent metabolic tracer, 18F-fluorocholine (FCH), for the detection of multiple myeloma lesions at time of initial extension assessment.\n\nThe principal objective of this sudy is to compare the number of suspected hypermetabolic foci of myeloma detected by 18F-fluorocholine PET and by 18F-fluorodeoxyglucose PET during the initial extension assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with initial diagnosis of multiple myeloma has just been established\n* Therapeutic indication and eligible for a HSC autograft (if the HSC autograft could not be performed, the patient will still be retained in the study).\n* Status ECOG 0, 1 or 2\n* Age ≥ 18 and \\< 75 ans years\n* Effective contraception for women\n* Informed consent signed\n* Patient able to lie flat for 30 minutes\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Patient diagnosed with a diagnosis of MGUS (Monoclonal Gammapathy of Undetermined Significance = monoclonal gammopathy of undetermined significance), indolent myeloma ("smoldering myeloma"), non-secreting myeloma or recurrent myeloma,\n* Patient already under treatment for myeloma.\n* Patient not eligible for intensive treatment followed by a HSC autograft.\n* Patient with concomitant neoplasia\n* Patient with a history of hematological or solid neoplasia, except if it is a basal cell carcinoma of the skin or an adenocarcinoma in situ of the uterine cervix.\n* Patient with a history of sarcoidosis\n* Uncontrolled diabetes.\n* Patient treated with long-term corticosteroids\n* Patient being treated with hematopoietic growth factors\n* Patient in sepsis.\n* Claustrophobic patient.\n* Refusal of patient consent.\n* Pregnant or lactating woman.\n* Women of childbearing potential without effective contraception.\n* Person deprived of liberty or under guardianship\n* Impossibility to submit to the medical follow-up of the trial for geographic, social or psychological reasons.\n* History of allergic reaction attributed to 18F-fluorodeoxyglucose or to 18F-fluorocholine.'}, 'identificationModule': {'nctId': 'NCT04349358', 'acronym': 'MIM', 'briefTitle': 'FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Georges Francois Leclerc'}, 'officialTitle': '18F-Fluorocholine (FCH) Versus 18F-Fluorodesoxyglucose (FDG) PET/CT in Detection of Lesions in Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': '2019-003627-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FDG and FCH PET/CT', 'interventionNames': ['Other: FDG and FCH PET/CT']}], 'interventions': [{'name': 'FDG and FCH PET/CT', 'type': 'OTHER', 'description': '* during the initial myeloma check-up : FDG and FCH PET/CT exams (maximum 21 days after inclusion)\n* just before maintenance treatment, respecting a minimum interval of 2 weeks after the last course of chemotherapy : FDG and FCH PET/CT exams', 'armGroupLabels': ['FDG and FCH PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean FONTAN', 'role': 'CONTACT'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clement DROUET', 'role': 'CONTACT'}], 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Denis CAILLOT', 'role': 'CONTACT'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Emilie REDERSTORFF', 'role': 'CONTACT', 'email': 'erederstorff@cgfl.fr', 'phone': '03 43 34 81 16'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Georges Francois Leclerc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}