Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 5:45 PM
Study NCT ID:
NCT03173469
Status:
COMPLETED
Last Update Posted:
2019-06-25
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Breast Magnetic Resonance Imaging for Patients Undergoing Mammoplasty
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-23', 'studyFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients whom MRI finding that will change the decision of surgery', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'all female with operable breast cancer seeking health care at general surgery department Assiut university hospitals,and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography, will undergo MRI breast, and see if MRI finding will change decision of the surgery.', 'detailedDescription': '* Study Setting: Assiut university hospital, general surgery department (C unit )\n* Study subjects: all female with operable breast cancer seeking health care at general surgery department and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography.\n\nThe size, number, and location of breast cancer lesions were identified on US and mammography.\n\nAlso size, number, location, pattern of enhancement and presence or absence of intraductal component will be evaluated by preoperative MRI.\n\nThe surgical plane will be decided based on US and mammography findings. The final decision will be based on MRI findings. When the initial surgical decision was the same as final decision the patient will be assigned to the unchanged group.\n\nHowever, if the final decision differed from the initial surgical decision the patient will be assigned to the changed group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All female with operable breast cancer who candidate fot therapeutic mammoplasty,Sample size was calculated using G power, it is 40 patients.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient with operable breast cancer (stage 1 and 2 ) Patient meet the criteria of therapeutic mammoplasty\n\nExclusion Criteria:\n\n* Inoperable breast cancer (stage 3 and 4) Breast cancer size \\> 4 cm in diameter Previous radiotherapy Local recurrence after previous breast conservation surgery Male breast cancer'}, 'identificationModule': {'nctId': 'NCT03173469', 'briefTitle': 'Preoperative Breast Magnetic Resonance Imaging for Patients Undergoing Mammoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Role of Preoperative Breast Magnetic Resonance Imaging for Surgical Decision in Patients Undergoing Therapeutic Mammoplasty', 'orgStudyIdInfo': {'id': 'MRIbreast'}}, 'armsInterventionsModule': {'interventions': [{'name': 'magnetic resonance imaging of breast', 'type': 'OTHER', 'description': 'all patients will undergo preoperative MRI'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university hospitals', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'A maher', 'investigatorAffiliation': 'Assiut University'}}}}