Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06988020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-30
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Pseudo-scanner" MRI Sequences for the Detection of Bone Lesions in Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the diagnostic performance of the different imaging protocols', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The diagnostic performance of the different imaging protocols will be evaluated by analyzing the receptor efficiency function (ROC curve) and by estimating the Sensitivity (Se), Specificity (Sp), Positive Predictive Value (PPV), Negative Predictive Value (NPV) ) as well as the Predictive Accuracy (Acc) of the different imaging protocols.'}], 'secondaryOutcomes': [{'measure': 'Comparison of Sensitivity (Se) and Predictive Precision (Acc) of the different imaging protocols', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'McNemar test on paired data. The Gold Standard will be determined by a panel of independent experts based on all available imaging techniques.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone', 'imaging', 'mri', 'multiple myeloma'], 'conditions': ['Multiple Myeloma Bone Disease']}, 'referencesModule': {'references': [{'pmid': '39377681', 'type': 'BACKGROUND', 'citation': 'Lecouvet FE, Zan D, Lepot D, Chabot C, Vekemans MC, Duchene G, Chiabai O, Triqueneaux P, Kirchgesner T, Taihi L, Poujol J, Gheysens O, Michoux N. MRI-based Zero Echo Time and Black Bone Pseudo-CT Compared with Whole-Body CT to Detect Osteolytic Lesions in Multiple Myeloma. Radiology. 2024 Oct;313(1):e231817. doi: 10.1148/radiol.231817.'}, {'pmid': '11371335', 'type': 'BACKGROUND', 'citation': 'Lecouvet FE, Vande Berg BC, Malghem J, Maldague BE. Magnetic resonance and computed tomography imaging in multiple myeloma. Semin Musculoskelet Radiol. 2001;5(1):43-55. doi: 10.1055/s-2001-12920.'}, {'pmid': '31844960', 'type': 'BACKGROUND', 'citation': 'Lecouvet FE, Boyadzhiev D, Collette L, Berckmans M, Michoux N, Triqueneaux P, Pasoglou V, Jamar F, Vekemans MC. MRI versus 18F-FDG-PET/CT for detecting bone marrow involvement in multiple myeloma: diagnostic performance and clinical relevance. Eur Radiol. 2020 Apr;30(4):1927-1937. doi: 10.1007/s00330-019-06469-1. Epub 2019 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'Recent work has confirmed the diagnostic performance of pseudo-CT sequences for detecting osteolytic lesions. Their integration into whole body MRI (WB MRI) could transform the diagnostic approach to MM, by allowing a combined assessment of bone marrow involvement, tissue viability and osteolysis, during a single non-irradiating imaging examination. Since the preliminary work mentioned above, optimizations have been made to the pseudo-CT sequences, including the addition of deep learning (correcting noise in the images) and the correction of chemical shift artifact (linked to the coexistence of hydrated tissue and fatty tissue), which carry real hope of improving their diagnostic potential and accuracy.', 'detailedDescription': 'Currently recommended imaging techniques for detecting bone lesions include whole-body MRI (WB-MRI), computed tomography (CT), and PET-CT. WB-MRI and PET-CT outperform CT for assessing treatment response, with WB-MRI already being the imaging modality of choice in many countries. However WB-MRI, the technique of choice for detecting bone marrow involvement, does not allow visualization of mineral bone, limiting its ability to accurately assess osteolysis. Zero Echo Time (ZTE) and Lava Flex Low Flip Angle (LF) MRI sequences represent a major advance, providing visualization of tissues at very short T2 relaxation times with resolution close to that of CT. These new sequences (known as pseudo-CT or pseudo-CT) offer for the first time the opportunity to study mineral bone by MRI, thus considerably increasing the diagnostic potential of this modality in MM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient with newly diagnosed multiple myeloma, for whom bone imaging is required for staging.\n\n* Recurrent patient after intensive treatment (high dose chemotherapy, bone marrow transplant, etc.).\n* Patient requiring a PET / CT considered as the technique of choice in these stages of the disease.\n\nExclusion Criteria:\n\n* Implanted material incompatible with MRI.\n* Severe claustrophobia.\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT06988020', 'acronym': 'MM-ZTE-II', 'briefTitle': '"Pseudo-scanner" MRI Sequences for the Detection of Bone Lesions in Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Evaluation of Optimised Whole-body MRI Examinations Incorporating "Pseudo-scanner" Sequences (ZTE, "Zero Echo Time" AND Lava Flex) for the Detection of Bone Lesions in Multiple Myeloma', 'orgStudyIdInfo': {'id': '2025/13FEV/071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Whole body MRI', 'description': 'There is only one cohort where each patient have the standard of care follow up (PET/CT) and Whole body MRI- ZTE sequence for the study', 'interventionNames': ['Device: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'Whole body MRI including ZTE sequences', 'armGroupLabels': ['Whole body MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'contacts': [{'name': 'Frederic Emmanuel Lecouvet, Md PhD', 'role': 'CONTACT', 'email': 'frederic.lecouvet@saintluc.uclouvain.be', 'phone': '+3227652793'}, {'name': 'Perrine Triqueneaux, Msc', 'role': 'CONTACT', 'email': 'perrine.triqueneaux@saintluc.uclouvain.be', 'phone': '027642935'}, {'name': 'Frédéric Lecouvet, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cliniques Universitaires Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'contacts': [{'name': 'Frédéric Lecouvet', 'role': 'CONTACT', 'email': 'frederic.lecouvet@saintluc.uclouvain.be', 'phone': '+3227642793'}, {'name': 'Perrine Triqueneaux', 'role': 'CONTACT', 'email': 'perrine.triqueneaux@saintluc.uclouvain.be'}, {'name': 'Frédéric Lecouvet', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Frédéric Lecouvet', 'role': 'CONTACT', 'email': 'frederic.lecouvet@saintluc.uclouvain.be', 'phone': '+3227642793'}, {'name': 'Perrine Triqueneaux', 'role': 'CONTACT', 'email': 'perrine.triqueneaux@saintluc.uclouvain.be'}], 'overallOfficials': [{'name': 'Frédéric Lecouvet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Ethic reason'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'collaborators': [{'name': 'General Electric', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}