Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-04 @ 6:53 PM
Study NCT ID:
NCT04468867
Status:
UNKNOWN
Last Update Posted:
2020-07-13
First Post:
2020-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumour size', 'timeFrame': '20 mins', 'description': 'Response will be assessed using RECIST criteria. Longest diameter response was scored based on the RECIST guidelines (PD\\>20% increase, SD\\<20% increase to\\<30% decrease, PR\\>30% decrease in longest diameter and CR if no tumour is visible).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Some women who have been diagnosed with a breast cancer will require chemotherapy as part of their treatment. The chemotherapy can be given before breast surgery - neoadjuvant chemotherapy or after breast surgery - adjuvant chemotherapy. Whether chemotherapy is given before or after does not affect the clinical outcomes for the woman - ie there is no disadvantage to the woman. Due to the fact that giving chemotherapy before has no disadvantages, many of the oncologists like to give the chemotherapy before because they can see if the breast cancer is responding. They are able to do this by using imaging. The best imaging test is breast MRI. Ultrasound can be used but studies have shown that it is not as good. However, whole breast ultrasound (ABUS) provides 3 dimensional information similar to breast MRI and the purpose of our study is to see if ABUS performs similar to breast MRI in being able to see if a tumour is responding to the chemotherapy. The breast MRI requires women to lie facing down and takes about 20mins. It involves an injection of contrast called gadolinium via a cannula. ABUS involves scanning the whole breast with the patient lying on their back and takes 10mins. There is no injection of contrast. MRI is an expensive test and often there is limited access to the scanner and so patients may have to wait for an appointment. ABUS because it is an automated process for obtaining the images can be performed in the breast unit in a timely manner without the issue of competing demands. All women who agree to take part in the study will have both the breast MRI - standard or care and the ABUS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All female participants eligible for neoadjuvant chemotherapy and planning surgical treatment\n2. Able to give informed consent\n\nExclusion Criteria:\n\n1. All female particpants having neoadjuvant chemotherapy as palliative treatment with no surgery planned\n2. Unable to provide informed consent\n3. Unable to have breast MRI scan due to clautrophobia or allergy to gadolineum'}, 'identificationModule': {'nctId': 'NCT04468867', 'acronym': 'RABUS', 'briefTitle': 'Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'officialTitle': 'Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'RD19/121361'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient group', 'interventionNames': ['Diagnostic Test: Automated whole breast ultrasound', 'Diagnostic Test: Breast MRI']}], 'interventions': [{'name': 'Automated whole breast ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'This will be performed by a band 6 radiographer and will be done at baseline, post 2 cycles of chemotherapy and end of treatment chemotherapy', 'armGroupLabels': ['Patient group']}, {'name': 'Breast MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'This will be performed by band 6 or 7 radiographer with MRI training', 'armGroupLabels': ['Patient group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'West Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nisha Sharma, mMBChB, MRCP (UK), FRCR', 'role': 'CONTACT'}], 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'centralContacts': [{'name': 'Nisha Sharma, mMBChB, MRCP (UK), FRCR', 'role': 'CONTACT', 'email': 'nisha.sharma2@nhs.net', 'phone': '0113 2063798'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}