Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-24 @ 9:26 PM
Study NCT ID:
NCT04097366
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2019-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Screening - Risk Adaptive Imaging for Density
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2019-09-09', 'studyFirstSubmitQcDate': '2019-09-18', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer detection rate in each arm', 'timeFrame': '42 months after mammogram at study entry', 'description': 'All cancers (detected or interval) in each arm over a three year period will be collected.'}], 'secondaryOutcomes': [{'measure': 'Incidence of stage II or worse cancers over the period of observation', 'timeFrame': '42 months after last participant entered', 'description': 'size, lymph node status, metastatic status'}, {'measure': 'The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.', 'timeFrame': '6 months after mammogram at study entry', 'description': 'Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates at prevalent round'}, {'measure': 'The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.', 'timeFrame': '21 months after mammogram at study entry', 'description': 'Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates'}, {'measure': 'The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.', 'timeFrame': '42 months after last participant entered', 'description': 'Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates at incident round; Interval cancer rate; Stage of interval cancers; Size of interval cancers'}, {'measure': 'Reading time of each examination', 'timeFrame': '1 year', 'description': 'Average time and range for each modality. (Seconds).'}, {'measure': 'Automated breast density measurements compared with reader assessment', 'timeFrame': 'Baseline', 'description': 'Percentage density.'}, {'measure': 'The risk of developing breast cancer as assessed by the BOADICEA model', 'timeFrame': '72 months After last participant entered', 'description': 'Percentage 5 year risk, percentage lifetime risk.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '40412427', 'type': 'DERIVED', 'citation': 'Gilbert FJ, Payne NR, Allajbeu I, Yit L, Vinnicombe S, Lyburn I, Sharma N, Teh W, James J, Seth A, Suaris T, Aggarwal R, Al-Attar M, Savaridas S, Antoniou A, Pharoah P, Duffy S. Comparison of supplemental breast cancer imaging techniques-interim results from the BRAID randomised controlled trial. Lancet. 2025 May 31;405(10493):1935-1944. doi: 10.1016/S0140-6736(25)00582-3. Epub 2025 May 21.'}]}, 'descriptionModule': {'briefSummary': 'BRAID is a randomised, multi-centre study assessing the impact of supplementary imaging in the detection of breast cancer in women participating in the UK national breast screening programme who have dense breast tissue.', 'detailedDescription': "Breast density is a measure of the amount of fibroglandular tissue and is a risk factor for breast cancer. Women with extremely dense breasts are at 4-fold increased breast cancer risk compared to women with 'fatty' breasts. High breast density reduces the sensitivity of mammography increasing the probability of the test missing a cancer. Women with dense breasts have their cancers found when the cancer is larger as they present with interval cancers or their cancers are not detected until the next screening round at a later stage.\n\nThe UK national breast screening programme (NHS BSP) offers all women aged 50-70 screening with 3-yearly mammograms. It aims to reduce breast cancer mortality by 20% by detecting small cancers thereby reducing the number of late stage diagnoses. However only 53% of the cancers being detected are small (\\<15mm). This is partly due to masking of cancers by dense breast tissue.\n\nThis trial addresses how best to screen women with dense breasts for breast cancer. BRAID will randomise women whose recent screening normal mammogram shows that they have dense breasts to either standard of care (no supplementary imaging) or supplementary imaging with abbreviated MRI (ABB-MRI), automated whole breast ultrasound (ABUS) or contrast enhanced spectral mammography (CEM). These imaging techniques have been shown to be more sensitive than mammography at detecting cancers in dense breast tissue. Our hypothesis is that more cancers will be detected at an earlier stage with supplemental imaging."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to give written informed consent\n* Willing and able to comply with the scheduled study visits, tests and other procedures\n* Female\n* Screening mammogram that is either normal or being recalled for assessment\n* Increased breast density identified on current screening mammogram examination (BIRADS C or D)\n\n * If BIRADS C the reporting radiologist should use clinical judgement as to eligibility, there should be a high chance of a cancer being masked in this participant\n * All BIRADS D will be eligible\n* Aged 50-70 and eligible for 3-yearly NHS breast screening\n\nExclusion Criteria:\n\n* Known BRCA carrier or ≥50% risk of being a carrier\n* Unable to give informed consent\n* Breast implant(s)\n* Unable to be followed-up for the study duration\n* Current participation in another interventional breast screening trial (Including but not limited to MyPeBS)\n* Participated in part A of the BRAID study\n* Pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT04097366', 'acronym': 'BRAID', 'briefTitle': 'Breast Screening - Risk Adaptive Imaging for Density', 'organization': {'class': 'OTHER', 'fullName': 'University of Cambridge'}, 'officialTitle': 'Breast Screening - Risk Adaptive Imaging for Density', 'orgStudyIdInfo': {'id': 'A095053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abbreviated MRI (ABB-MRI)', 'description': 'Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram.', 'interventionNames': ['Diagnostic Test: ABB-MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Automated Breast Ultrasound (ABUS)', 'description': 'Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.', 'interventionNames': ['Diagnostic Test: ABUS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Contrast Enhanced Mammography (CEM)', 'description': 'Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram.', 'interventionNames': ['Diagnostic Test: CEM']}], 'interventions': [{'name': 'ABUS', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Whole Breast Ultrasound', 'Automated Breast Ultrasound'], 'description': 'Automated whole breast ultrasound (ABUS) is undertaken with a large transducer panel placed on the breast in three positions. Resultant images are combined to make a 3D image of the breast.', 'armGroupLabels': ['Automated Breast Ultrasound (ABUS)']}, {'name': 'CEM', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Contrast Enhanced Mammography'], 'description': 'A high kV and a low kV image is taken in two standard views of each breast following the intravenous injection of an iodinated contrast agent.', 'armGroupLabels': ['Contrast Enhanced Mammography (CEM)']}, {'name': 'ABB-MRI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Abbreviated Magnetic Resonance Imaging', 'Abridged MRI', 'Abbreviated Protocol MRI', 'Abbreviated Breast MRII'], 'description': 'ABB-MRI is a shorter version of breast MRI. Standard T1W pre and post contrast images are acquired. A MIP and post-contrast T1 weighted image are read.', 'armGroupLabels': ['Abbreviated MRI (ABB-MRI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Dundee', 'country': 'United Kingdom', 'facility': 'Tayside Health Board, Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'G12 0XH', 'city': 'Glasgow', 'state': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Greater Glasgow Health Board, Gartnavel Royal Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'University Hospitals of Leicester, Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'E1 1FR', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust, Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free London NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust, City Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'GL53 7AS', 'city': 'Cheltenham', 'country': 'United Kingdom', 'facility': 'Gloucestershire Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'The Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Fiona Gilbert', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cambridge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Research UK', 'class': 'OTHER'}, {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, {'name': 'Queen Mary University of London', 'class': 'OTHER'}, {'name': 'Public Health England', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology and Head of Department', 'investigatorFullName': 'Fiona J Gilbert', 'investigatorAffiliation': 'University of Cambridge'}}}}