Tomosynthesis Mammography Imaging Screening Trial

Official Title

Tomosynthesis Mammography Imaging Screening Trial Lead-in

Summary:

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.

Trial Description

Primary Outcome:

  • Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
Secondary Outcome:
  • Recall Rates
  • Interval Cancers
  • Prevalence of Breast Cancer Subtypes
  • Clinical Characteristics of Cancers
  • Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison
  • Biomarker Correlation
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society