🏛️ Verified NIH Record • Updated 2025-05-16

Tomosynthesis Mammographic Imaging Screening Trial (NCT02616432)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Sunnybrook Health Sciences Centre

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (7 items).

Location: X-Ray 505 (Under the BCCA Screening Mammography Program of BC) — Vancouver, British Columbia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

  • X-Ray 505 (Under the BCCA Screening Mammography Program of BC) — Vancouver, British Columbia
  • Breast Health Centre at BC Women's Hospital + Health Centre — Vancouver, British Columbia
  • The Ottawa Hospital — Ottawa, Ontario
  • Sunnybrook Health Sciences Centre — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗