Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-01 @ 10:44 PM
Study NCT ID:
NCT02616432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2015-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tomosynthesis Mammographic Imaging Screening Trial
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': 'D008327', 'term': 'Mammography'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3065}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2015-11-10', 'studyFirstSubmitQcDate': '2015-11-24', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison', 'timeFrame': '3 year follow-up', 'description': 'To compare the diagnostic accuracy using the area under the curve (AUC) score generated by receiver operator characteristic (ROC) analysis of digital breast tomosynthesis plus full-field digital mammography (DBT) versus full-field digital mammography (FFDM) alone for breast cancer screening. The examinations will be interpreted by local Breast Imaging radiologists. Cancer status will be pathologically confirmed. The women would undergo three consecutive screening rounds in the assigned arm followed by one year of standard of care imaging follow-up.'}], 'secondaryOutcomes': [{'measure': 'Recall Rates', 'timeFrame': '3 year', 'description': 'To compare the recall rates due to abnormal screening examinations for DBT versus FFDM when used for breast cancer screening.'}, {'measure': 'Interval Cancers', 'timeFrame': '3 year', 'description': 'To compare the number of interval cancers missed with DBT versus FFDM use in breast cancer screening.'}, {'measure': 'Prevalence of Breast Cancer Subtypes', 'timeFrame': '3 year', 'description': 'To estimate the prevalence of breast cancer subtypes (Luminal A, Luminal B, HER2neu, Basal-like, Claudin-low) by DBT and FFDM, stratified on whether cancers were detected in screening or as interval cancers.'}, {'measure': 'Clinical Characteristics of Cancers', 'timeFrame': '3 year', 'description': 'To assess and compare clinical characteristics (e.g. stage, grade, ER, PR, and HER2status) of cancers detected from screening by DBT and FFDM. Approximately 75 genes will be assayed in tumors detected in each arm of the study to evaluate breast cancer molecular subtype.'}, {'measure': 'Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison', 'timeFrame': '4 year', 'description': 'To assess different combinations of FFDM, tomosynthesis and synthesized FFDM images in reader studies to assist in determining the optimum balance between radiation exposure and technique. AUC of ROC curves will be used to compare combinations. A panel of radiologists will read the various combinations of images in random order to assess whether tomosynthesis with synthetic 2D images is as accurate as tomosynthesis with FFDM images. The latter will require more radiation exposure.'}, {'measure': 'Biomarker Correlation', 'timeFrame': '2 year', 'description': 'Biomarker correlation to characterize disease in the tumor and compare to the tissue immediately adjacent to it.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tomosynthesis', 'Digital Breast Tomosynthesis (DBT)', 'Breast Imaging', 'Full-field digital mammography', 'Breast screening'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'A randomized screening trial to compare the diagnostic accuracy of screening for breast cancer with three-dimensional digital breast tomosynthesis (DBT) plus two-dimensional full-field digital mammography (FFDM) versus FFDM alone.', 'detailedDescription': 'The Tomosynthesis Mammography Imaging Screening Trial (TMIST) LEAD-IN is being conducted to ensure that all Eastern Cooperative Oncology Group / American College of Radiology Imaging Network (ECOG/ACRIN) TMIST components are properly functional and to provide an opportunity for fine tuning before launching the full TMIST. The accrual target for TMIST LEAD-IN is 6354 participants (one tenth of the projected enrollment target for TMIST) at three lead-in study sites: 1. Sunnybrook Health Sciences Centre in Toronto, 2. Vancouver (under the auspices of the Screening Mammography Programme of British Columbia) and 3. The Ottawa Hospital.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic women age 40 and over\n* Scheduled for screening mammogram\n* Able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol\n* Willing and able to provide a written informed consent.\n\nExclusion Criteria:\n\n* Presenting for mammography with symptoms of breast disease\n* Have new breast complaints (e.g. lump, nipple discharge)\n* Have had a mammogram of both breasts within the last 11 months\n* Previous personal history of breast cancer\n* Has breast enhancements (e.g. implants or injections)\n* Pregnancy or intent to become pregnant.'}, 'identificationModule': {'nctId': 'NCT02616432', 'acronym': 'TMISTLead-in', 'briefTitle': 'Tomosynthesis Mammographic Imaging Screening Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Tomosynthesis Mammography Imaging Screening Trial Lead-in', 'orgStudyIdInfo': {'id': '001-2014b'}, 'secondaryIdInfos': [{'id': '410000662', 'type': 'OTHER_GRANT', 'domain': 'Canadian Breast Cancer Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tomosynthesis + FFDM', 'description': 'Women enrolled to DBT Arm will undergo manufacturer-defined DBT', 'interventionNames': ['Device: Tomosynthesis']}, {'type': 'NO_INTERVENTION', 'label': 'FFDM - Standard of Care for Screening', 'description': 'Women enrolled to the FFDM Arm will undergo bilateral digital mammogram with standard CC and MLO views acquired'}], 'interventions': [{'name': 'Tomosynthesis', 'type': 'DEVICE', 'description': 'Three-dimensional imaging of both breasts in standard CC and MLO views', 'armGroupLabels': ['Tomosynthesis + FFDM']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1H4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'X-Ray 505 (Under the BCCA Screening Mammography Program of BC)', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Breast Health Centre at BC Women's Hospital + Health Centre", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Roberta A Jong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediate', 'ipdSharing': 'YES', 'description': 'ECOG/ACRIN TMIST will collect all data when accrual starts for that trial.', 'accessCriteria': 'ECOG/ACRIN Sharing Access policy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Roberta Jong', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}