Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT03592004
Status:
UNKNOWN
Last Update Posted:
2018-07-19
First Post:
2018-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer
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': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2018-06-26', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'predicting pathological complete response (pCR) or no response (NR)', 'timeFrame': '20 weeks', 'description': 'The value of Radiomics of multiparametric MRI in predicting responses to neoadjuvant chemotherapy, including pathological complete response (pCR) and no response (NR).'}, {'measure': '5 years for Disease free survival', 'timeFrame': '5 years', 'description': 'The association between Radiomics of multiparametric MRI and disease free survival (DFS), which defined as the time from the beginning of neoadjuvant chemotherapy to the confirmed time of recurrence or metastatic disease, or death due to any other cause.'}, {'measure': '5 years for Overall survival', 'timeFrame': '5 years', 'description': 'The association between Radiomics of multiparametric MRI and overall survival (OS), which defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Radiomics', 'Neoadjuvant Chemotherapy', 'Multi-parametric MRI']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, multicentre study that aims to assess whether Radiomics combining multiparametric MRI and clinical data could be a good predictor of the responses to neoadjuvant chemotherapy in Breast Cancer.', 'detailedDescription': 'Patients undergo multiparametric MRI (including T2WI, DWI and DCE-MRI) at baseline, after 2 courses of neoadjuvant chemotherapy, and prior to the surgery at least 8 weeks after the treatment procedure. Patients undergo biopsy test in one week after the baseline MRI scan to detect the biomarkers including ER, PR, Her-2 and Ki-67, which can be used to select the treatment plan referring to the NCCN clinical guidelines. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens.\n\nAfter completion of treatment procedure, patients are followed up for 5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy-proven invasive breast cancer;\n* received complete neoadjuvant chemotherapy and no treatment has been done before;\n* surgery was performed after completion of neoadjuvant chemotherapy, after which pCR was confirmed by postoperative pathological examination;\n* pretreatment MRI data within a month before the start of the treatment was eligible, including T2WI, DWI and DCE-MRI.\n\nExclusion Criteria:\n\n* not completing neoadjuvant chemoradiotherapy;\n* not undergoing surgery at our hospital, or pCR was not assessed;\n* lack of T2WI, or DWI or DCE-MRI data;\n* insufficient MRI quality to obtain measurements (e.g., owing to motion artifacts);\n* had unilateral multifocal cancers, and the correlation between the tumor in MR images and postoperative pathological examination was uncertain.'}, 'identificationModule': {'nctId': 'NCT03592004', 'briefTitle': 'Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Chinese Academy of Sciences'}, 'officialTitle': 'Radiomics of Multiparametric MRI for Neoadjuvant Chemotherapy Outcomes Assessment in Breast Cancer', 'orgStudyIdInfo': {'id': 'ZLiu'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Guangdong General Hospital', 'interventionNames': ['Other: neoadjuvant chemotherapy']}, {'label': 'Cancer Hospital Chinese Academy Of Medical Sciences', 'interventionNames': ['Other: neoadjuvant chemotherapy']}, {'label': 'Beijing Friendship Hospital', 'interventionNames': ['Other: neoadjuvant chemotherapy']}, {'label': 'Yunnan Cancer Hospital', 'interventionNames': ['Other: neoadjuvant chemotherapy']}, {'label': 'Liaoning Cancer Hospital', 'interventionNames': ['Other: neoadjuvant chemotherapy']}, {'label': 'The First Hospital Of China Medical University', 'interventionNames': ['Other: neoadjuvant chemotherapy']}, {'label': 'Affiliated Hospital Of Hebei University', 'interventionNames': ['Other: neoadjuvant chemotherapy']}], 'interventions': [{'name': 'neoadjuvant chemotherapy', 'type': 'OTHER', 'description': 'neoadjuvant chemotherapy', 'armGroupLabels': ['Affiliated Hospital Of Hebei University', 'Beijing Friendship Hospital', 'Cancer Hospital Chinese Academy Of Medical Sciences', 'Guangdong General Hospital', 'Liaoning Cancer Hospital', 'The First Hospital Of China Medical University', 'Yunnan Cancer Hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100190', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenyu Liu, Doctor', 'role': 'CONTACT', 'phone': '8613466358609'}], 'facility': 'Zhenyu Liu', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhenyu Liu, Doctor', 'role': 'CONTACT', 'email': 'zhenyu.liu@ia.ac.cn', 'phone': '8613466358609'}], 'overallOfficials': [{'name': 'Jie Tian, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'Yunnan Cancer Hospital', 'class': 'OTHER'}, {'name': 'Liaoning Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Hebei University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zhenyu Liu', 'investigatorAffiliation': 'Chinese Academy of Sciences'}}}}