NCT02616432

Tomosynthesis Mammographic Imaging Screening Trial

Tomosynthesis Mammography Imaging Screening Trial Lead-in

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,065 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Tomosynthesis	Three-dimensional imaging of both breasts in standard CC and MLO views

Timeline

• Start date: 2014-10-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2015-11-27
• Last updated: 2025-05-21

Locations

4 sites across 1 country: Canada