Tomosynthesis Mammography Imaging Screening Trial Lead-in
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 3065
- Locations
- 4
- Primary Endpoint
- Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Dr. Roberta Jong
Principal Investigator
Sunnybrook Health Sciences Centre
Eligibility Criteria
Inclusion Criteria
- •Asymptomatic women age 40 and over
- •Scheduled for screening mammogram
- •Able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol
- •Willing and able to provide a written informed consent.
Exclusion Criteria
- •Presenting for mammography with symptoms of breast disease
- •Have new breast complaints (e.g. lump, nipple discharge)
- •Have had a mammogram of both breasts within the last 11 months
- •Previous personal history of breast cancer
- •Has breast enhancements (e.g. implants or injections)
- •Pregnancy or intent to become pregnant.
Outcomes
Primary Outcomes
Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
Time Frame: 3 year follow-up
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.
Secondary Outcomes
- Recall Rates(3 year)
- Interval Cancers(3 year)
- Prevalence of Breast Cancer Subtypes(3 year)
- Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison(4 year)
- Biomarker Correlation(2 year)
- Clinical Characteristics of Cancers(3 year)