Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT05744518
Status:
UNKNOWN
Last Update Posted:
2023-02-27
First Post:
2023-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring Response to Neoadjuvant Chemotherapy in Breast Cancer Using Ultrafast DCE-MRI
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-24', 'studyFirstSubmitDate': '2023-01-28', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Pathologic Response (pCR)', 'timeFrame': '6 Months Post Surgery', 'description': 'The primary aim of this feasibility study is to determine whether ultrafast dynamic contrasted-enhancement magnetic resonance imaging (DCE-MRI) at baseline prior to first cycle neoadjuvant chemotherapy (NAC), after first cycle NAC, and prior to second cycle NAC can accurately predict complete pathologic response (pCR) in women with breast cancer.'}], 'secondaryOutcomes': [{'measure': 'Image Quality', 'timeFrame': '6 Months Post Surgery', 'description': 'The second aim of this feasibility study is to determine whether ultrafast dynamic contrasted-enhancement magnetic resonance imaging (DCE-MRI) can provide the relatively high resolution, high contrast-noise ration, and good contrast with ultrafast DCE-MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The study will assess whether changes in kinetic parameters of tumor and peritumoral vasculature using ultrafast dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) during neoadjuvant chemotherapy (NAC) are predictive of pathologic complete response (pCR) in patients with breast cancer appropriate for NAC. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible female breast cancer patients receiving NAC at Fudan University Shanghai Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female;\n2. Age 18 years or older;\n3. Diagnosis of invasive breast cancer by ultrasound guided biopsy;\n\n3\\. Planed for receiving neoadjuvant chemotherapy (NAC) 4. Planned definitive breast surgery following completion of NAC.\n\nExclusion Criteria:\n\n1. Stage IV breast cancer;\n2. Previous ipsilateral breast cancer;\n3. Previous treatment (chemotherapy or radiation) to involved breast;\n4. Medically unstable;\n5. Pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT05744518', 'briefTitle': 'Monitoring Response to Neoadjuvant Chemotherapy in Breast Cancer Using Ultrafast DCE-MRI', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Monitoring Response to Neoadjuvant Chemotherapy in Breast Cancer Using Ultrafast Dynamic Contrasted-Enhancement Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'MR-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Response monitoring', 'type': 'OTHER', 'description': 'Other: Response monitoring (no intervention)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200232', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yajia Gu, MD', 'role': 'CONTACT', 'email': '7583724@qq.com', 'phone': '+8621-64175590'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yajia Gu, MD', 'role': 'CONTACT', 'email': '7583724@qq.com', 'phone': '+8618616876763'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Radiology, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Yajia Gu, MD', 'investigatorAffiliation': 'Fudan University'}}}}