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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
3,065
Three-dimensional imaging of both breasts in standard CC and MLO views
X-Ray 505 (Under the BCCA Screening Mammography Program of BC)
Vancouver, British Columbia, Canada
Breast Health Centre at BC Women's Hospital + Health Centre
Vancouver, British Columbia, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
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.
Time frame: 3 year follow-up
Recall Rates
To compare the recall rates due to abnormal screening examinations for DBT versus FFDM when used for breast cancer screening.
Time frame: 3 year
Interval Cancers
To compare the number of interval cancers missed with DBT versus FFDM use in breast cancer screening.
Time frame: 3 year
Prevalence of Breast Cancer Subtypes
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.
Time frame: 3 year
Clinical Characteristics of Cancers
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.
Time frame: 3 year
Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison
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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.
Time frame: 4 year
Biomarker Correlation
Biomarker correlation to characterize disease in the tumor and compare to the tissue immediately adjacent to it.
Time frame: 2 year