Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT03801850
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2018-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3D
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2019-01-09', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of breast morphology or volume changes during the breast irradiation on the total dose administered', 'timeFrame': 'Change of the dose delivered in the breast from the baseline treatment planification at the end of the treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)', 'description': 'To analyse the effect of morphological changes in the breast during breast radiotherapy on the dose really administered in the remaining mammary gland after breast-conserving surgery compared to the dose initially planned.'}], 'secondaryOutcomes': [{'measure': 'Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery', 'timeFrame': 'At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)'}, {'measure': 'Preliminary quantitative assessment of breast deformations (mm) during breast radiotherapy following breast cancer conservative surgery', 'timeFrame': 'At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)'}, {'measure': 'Breast deformation and volume measurements reproducibility', 'timeFrame': 'before treatment start', 'description': 'Evaluation of the reproducibility of deformation and volume measurements between 2 consecutive surface scan acquisition. Reproducibility was calculated in accordance with International Organization of Standardisation (ISO 5725-2) and American Society for Testing and Material E177'}, {'measure': 'Deviation between the breast volume calculated and the breast volume manually delineated', 'timeFrame': 'before treatment start', 'description': 'Evaluation of the difference between the initial breast volume calculated by the software developed for the study and the delineated volume'}, {'measure': 'Required measurement time (surface scan)', 'timeFrame': 'At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)', 'description': 'Mean time (in minutes) needed to perform a surface scan'}, {'measure': 'Correlation between textural data and radio-induced erythema', 'timeFrame': 'At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)'}, {'measure': 'Potential dose distribution alteration despite no variation of the 95Recalculated or the D2Recalculated', 'timeFrame': 'at the end of each treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['volume variation', 'deformation', 'repositioning', 'dosimetric quality', '3D scan'], 'conditions': ['Breast Cancer Female', 'Adjuvant Radiotherapy']}, 'descriptionModule': {'briefSummary': "Quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. Evaluation of the dosimetric impact of these variations."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* In situ or invasive breast carcinoma\n* Treated by conservative breast surgery\n* Pre-treatment with authorized chemotherapy\n* Eligible for conventional breast irradiation in 25 sessions of 2 Gy with or without irradiation of the tumor bed and lymph nodes area\n* Conventional 3D radiotherapy technique\n* Bra cup size from A to D included\n* Speaking and understanding french\n* Having given written consent\n* Patient with health insurance\n\nExclusion Criteria:\n\n* Surgical treatment by mastectomy\n* No indication for breast radiotherapy\n* Local or diffuse inflammatory state of the breast at inclusion\n* History of epilepsy or anticonvulsive treatment for preventive or curative purposes\n* BMI\\> 30kg / m2\n* T4 stage tumor\n* Bilateral breast tumor\n* Use of a ventilatory control to treat the patient\n* Minor patient or major incompetent\n* Patient deprived of liberty\n* Patient under safeguard of justice'}, 'identificationModule': {'nctId': 'NCT03801850', 'acronym': 'MB3D', 'briefTitle': "Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3D", 'organization': {'class': 'OTHER', 'fullName': 'Centre Paul Strauss'}, 'officialTitle': "Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D", 'orgStudyIdInfo': {'id': '2018-01'}, 'secondaryIdInfos': [{'id': '2017-A02489-44', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'observational cohort', 'interventionNames': ['Device: 3D surface scan']}], 'interventions': [{'name': '3D surface scan', 'type': 'DEVICE', 'description': 'measurement of inter fractional deformations by surface scanning', 'armGroupLabels': ['observational cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67065', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Georges NOEL, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Paul Strauss'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Paul Strauss', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}