Tomosynthesis Mammographic 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