Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 4:01 AM
Study NCT ID:
NCT01190566
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
2010-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'moonwk@snu.ac.kr', 'phone': '82-2-2072-2584', 'title': 'Woo Kyung Moon', 'organization': 'Seoul National University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline, post-1st chemotherapy, preoperative timing', 'eventGroups': [{'id': 'EG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'the absence of invasive tumor cells after surgery', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-pCR', 'description': 'the presence of invasive tumor cells after surgery', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patholocial Response to Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathologic Response to Chemotherapy', 'description': 'Degree of pathologic response to the neoadjuvant chemotherapy'}], 'classes': [{'title': 'Pathologic completer Responders (pCR)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Non-pCR', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-operation', 'description': 'Pathological complete response (pCR) or non-pCR', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tumor Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'the absence of invasive tumor cells after surgery'}, {'id': 'OG001', 'title': 'Non-pCR', 'description': 'the presence of invasive tumor cells after surgery'}], 'classes': [{'title': 'Baseline tumor size', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Post-1st chemotherapy tumor size', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, completion of 1st cycle of chemotherapy', 'description': 'Maximal tumor diameter measured on magnetic resonance imaging', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tumor Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'the absence of invasive tumor cells after surgery'}, {'id': 'OG001', 'title': 'Non-pCR', 'description': 'the presence of invasive tumor cells after surgery'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.0', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '89.8', 'groupId': 'OG001'}]}]}, {'title': 'Post-1st chemotherapy', 'categories': [{'measurements': [{'value': '11.0', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '44.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-1st chemotherapy', 'description': 'Tumor volume measured on 3-dimensional magnetic resonance imaging', 'unitOfMeasure': 'cm3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'the absence of invasive tumor cells after surgery'}, {'id': 'OG001', 'title': 'Non-pCR', 'description': 'the presence of invasive tumor cells after surgery'}], 'classes': [{'title': 'PRMSI+', 'categories': [{'measurements': [{'value': '14.0', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '27.2', 'groupId': 'OG001'}]}]}, {'title': 'PRMSI-', 'categories': [{'measurements': [{'value': '83.4', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '56.4', 'spread': '27.8', 'groupId': 'OG001'}]}]}, {'title': 'PRMSI0', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-1st chemotherapy', 'description': 'Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.', 'unitOfMeasure': '% of voxels', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'the absence of invasive tumor cells after surgery'}, {'id': 'OG001', 'title': 'Non-pCR', 'description': 'the presence of invasive tumor cells after surgery'}], 'classes': [{'title': 'Baseline Ktrans', 'categories': [{'measurements': [{'value': '0.263', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '0.254', 'spread': '0.080', 'groupId': 'OG001'}]}]}, {'title': 'Post-1st chemotherapy Ktrans', 'categories': [{'measurements': [{'value': '0.224', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '0.234', 'spread': '0.068', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-1st chemotherapy', 'unitOfMeasure': 'min-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'the absence of invasive tumor cells after surgery'}, {'id': 'OG001', 'title': 'Non-pCR', 'description': 'the presence of invasive tumor cells after surgery'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.616', 'spread': '0.262', 'groupId': 'OG000'}, {'value': '0.787', 'spread': '0.729', 'groupId': 'OG001'}]}]}, {'title': 'Post-1st chemotherapy', 'categories': [{'measurements': [{'value': '0.992', 'spread': '0.917', 'groupId': 'OG000'}, {'value': '0.616', 'spread': '0.298', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-1st chemotherapy', 'unitOfMeasure': 'min-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'the absence of invasive tumor cells after surgery'}, {'id': 'OG001', 'title': 'Non-pCR', 'description': 'the presence of invasive tumor cells after surgery'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.563', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '0.550', 'spread': '0.146', 'groupId': 'OG001'}]}]}, {'title': 'Post-1st chemotherapy', 'categories': [{'measurements': [{'value': '0.467', 'spread': '0.151', 'groupId': 'OG000'}, {'value': '0.557', 'spread': '0.136', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-1st chemotherapy', 'unitOfMeasure': 'unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'the absence of invasive tumor cells after surgery'}, {'id': 'OG001', 'title': 'Non-pCR', 'description': 'the presence of invasive tumor cells after surgery'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '15.0', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Post-1st chemotherapy', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '6.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-1st chemotherapy', 'description': 'Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.', 'unitOfMeasure': 'unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 48 participants, 13 participants did not undergo magnetic resonance spectroscopy examinations due to workflow problem. We included the available data from 35 participants.'}, {'type': 'SECONDARY', 'title': 'Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'the absence of invasive tumor cells after surgery'}, {'id': 'OG001', 'title': 'Non-pCR', 'description': 'the presence of invasive tumor cells after surgery'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '18.9', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Post-1st chemotherapy', 'categories': [{'measurements': [{'value': '9.7', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-1st chemotherapy', 'unitOfMeasure': 'unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.'}, {'id': 'FG001', 'title': 'Non-pCR', 'description': 'The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pathologic Complete Responders (pCR)', 'description': 'The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.'}, {'id': 'BG001', 'title': 'Non-pCR', 'description': 'The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '40 years old or less', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'more than 40 years old', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical stage (American Joint Committee on Cancer 7th edition)', 'classes': [{'title': 'Stage II', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Stage III', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Estrogen receptor', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Progesterone receptor', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HER2', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ki-67 (Cellular marker for proliferation)', 'classes': [{'title': '14% or less (low proliferation)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'more than 14% (high proliferation)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Immunohistochemical subtype', 'classes': [{'title': 'Hormone receptor positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Triple negative', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'HER2-positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Core biopsy specimens of breast cancer'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2010-08-25', 'resultsFirstSubmitDate': '2013-12-30', 'studyFirstSubmitQcDate': '2010-08-26', 'lastUpdatePostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-11', 'studyFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patholocial Response to Chemotherapy', 'timeFrame': 'Post-operation', 'description': 'Pathological complete response (pCR) or non-pCR'}], 'secondaryOutcomes': [{'measure': 'Tumor Size', 'timeFrame': 'baseline, completion of 1st cycle of chemotherapy', 'description': 'Maximal tumor diameter measured on magnetic resonance imaging'}, {'measure': 'Tumor Volume', 'timeFrame': 'Baseline, post-1st chemotherapy', 'description': 'Tumor volume measured on 3-dimensional magnetic resonance imaging'}, {'measure': 'Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)', 'timeFrame': 'Baseline, post-1st chemotherapy', 'description': 'Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.'}, {'measure': 'Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)', 'timeFrame': 'Baseline, post-1st chemotherapy'}, {'measure': 'Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)', 'timeFrame': 'Baseline, post-1st chemotherapy'}, {'measure': 'Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)', 'timeFrame': 'Baseline, post-1st chemotherapy'}, {'measure': 'Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy', 'timeFrame': 'Baseline, post-1st chemotherapy', 'description': 'Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.'}, {'measure': 'Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography', 'timeFrame': 'Baseline, post-1st chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Magnetic Resonance Imaging, Functional', 'Tomography, Positron-Emission', 'chemotherapy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24738612', 'type': 'DERIVED', 'citation': 'Cho N, Im SA, Park IA, Lee KH, Li M, Han W, Noh DY, Moon WK. Breast cancer: early prediction of response to neoadjuvant chemotherapy using parametric response maps for MR imaging. Radiology. 2014 Aug;272(2):385-96. doi: 10.1148/radiol.14131332. Epub 2014 Apr 13.'}], 'seeAlsoLinks': [{'url': 'http://bri.snuh.org/pub/_/singlecont/view.do', 'label': 'Homepage of Seoul National University Hospital Biomedical Research Institute'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\nTo validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.\n\nTo identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI, dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.\n\nTo compare the performances of dynamic contrast-enhanced MRI using parametric response map analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer patients', 'detailedDescription': 'Enrolled women with breast cancers who had received an anthracycline-taxane regimen and subsequent surgery were prospectively enrolled. DCE-MRI and FDG-PET scan were performed before and after the 1st cycle of chemotherapy. MR imaging parameters and SUV on PET scan within a tumor were analyzed. Clinicopathologic (age, clinical tumor stage, hormonal receptor status, and surgery type) and imaging parameters were compared according to the pathological response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients who are candidates for neoadjuvant chemotherapy, pre-treatment MRI and PET scan, post-treatment MRI and PET scan for evaluation of chemotherapy response monitoring and residual disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed breast cancer\n* Clinical stage IIb, IIIa, IIIb, IIIc\n* Must have measurable disease\n* Performance status of ECOG 0-2\n* Adequate, bone marrow, liver, heart, and renal function\n* Who did not receive chemotherapy for breast cancer\n* Must agree with and signed informed consent\n\nExclusion Criteria:\n\n* Prior history of cancer besides breast cancer\n* Active bacterial infection\n* Pregnant or lactating women\n* Psychological disease or seizure\n* History of arrhythmia, congestive heart failure, myocardial infarct, or unstable angina\n* Male breast cancer\n* Who had a pacemaker or history of open heart surgery'}, 'identificationModule': {'nctId': 'NCT01190566', 'briefTitle': 'PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'PET-MR Breast Cancer'}}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Woo Kyung Moon, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiology, Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health & Welfare, Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Woo Kyung Moon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}