Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02553967
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2015-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BOLD signal change (difference in intensity and anatomic location) in the regions activated during breast palpation between the reconstructed breast and the non-operated breast.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'BOLD signal change (difference in intensity and anatomic location) in the regions activated during breast palpation between the breast reconstructed using an autologous flap and a prosthesis.', 'timeFrame': '6 months'}, {'measure': 'BOLD signal change (difference in intensity and anatomic location) in the regions activated during breast palpation between the reconstructed breast and the mastectomy scar before reconstruction.', 'timeFrame': '6 months'}, {'measure': 'Topography variation in brain sensory projection area after total mastectomy and breast reconstruction.', 'timeFrame': '6 months'}, {'measure': 'Satisfaction score and pre and postoperative quality-of-life score (Breast Q) according to a Likert scale.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['functional Magnetic Resonance Imaging (fMRI)', 'Breast reconstructive surgery', 'Breast Q questionnaire'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and that would enable the patient to appropriate the reconstructed breast. Patient satisfaction assessed subjectively by questionnaires would be better in autologous reconstructions than in reconstructions by prosthesis.\n\nThe aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to describe the brain functional changes of sensory projections after immediate or secondary breast reconstruction.', 'detailedDescription': 'Patients responding criteria for selection and not objecting to participate in this trial will address a quality of life questionnaire at baseline. Then the study procedures differ depending on which group the patient belongs to.\n\nImmediate breast reconstruction group : Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form.\n\nSecondary breast reconstruction group :\n\n* In the two months preceding the surgery, a preoperative fMRI will be performed.\n* Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient with an indication of unilateral total mastectomy with immediate breast reconstruction for initial breast cancer or recurrence, Or patient undergoing a unilateral secondary breast reconstruction\n2. WHO performance status less than or equal to 2\n3. Age ≥ 18 years\n4. For patients of childbearing age, use of an effective contraceptive method for the duration of the study\n5. Patient having been informed and having signed an informed consent form for the study.\n\nExclusion Criteria:\n\n1. Patient undergoing a breast reconstruction by exclusive lipomodelling\n2. Contraindication to MRI : claustrophobia, intra-orbital metallic fragment, pregnancy, cochlear implants, incompatible metallic foreign body such as certain pacemaker and mechanical valves\n3. Patient with an indication of preoperative radiotherapy or adjuvant chemotherapy according to regional and/or national standards\n4. History of brain surgery\n5. History of contralateral breast surgery\n6. History of prophylactic total mastectomy\n7. Reconstruction techniques using a mixed procedure (autologous + prosthesis)\n8. Patient on medication that may alter the BOLD signal in MRI\n9. Pregnant or breastfeeding women\n10. Patient under tutorship or guardianship'}, 'identificationModule': {'nctId': 'NCT02553967', 'acronym': 'REMASCO', 'briefTitle': 'Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)', 'orgStudyIdInfo': {'id': 'REMASCO-1503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate breast reconstruction', 'description': '* Total mastectomy + immediate reconstructive surgery\n* 6 months after surgery : Functional MRI and questionnaires', 'interventionNames': ['Device: Functional MRI']}, {'type': 'EXPERIMENTAL', 'label': 'Secondary breast reconstruction', 'description': '* Within 2 months before surgery : Functional MRI\n* Reconstructive surgery\n* 6 months after surgery : Functional MRI and questionnaires', 'interventionNames': ['Device: Functional MRI']}], 'interventions': [{'name': 'Functional MRI', 'type': 'DEVICE', 'description': 'Functional MRI', 'armGroupLabels': ['Immediate breast reconstruction', 'Secondary breast reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Claudia REGIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Lille', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}