Tomosynthesis Screening for Breast Cancer
(TMISTLead-in Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byRoberta A Jong, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for asymptomatic women aged 40 and over who are scheduled for a routine screening mammogram. Participants must be able to undergo digital breast tomosynthesis and full-field digital mammography, and provide consent. Women with prior breast cancer, current or planned pregnancy, recent mammograms, breast enhancements, or new breast complaints cannot join.

Inclusion Criteria

I am scheduled for a screening mammogram.

I am a woman over 40 and do not have any symptoms.

Able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol

+1 more

Exclusion Criteria

I am experiencing symptoms of breast disease and need a mammogram.

I have noticed new issues with my breast, like a lump or discharge.

Pregnancy or intent to become pregnant.

+3 more

Participant Groups

The study aims to compare the effectiveness of two types of breast cancer screenings: one combining three-dimensional digital breast tomosynthesis (DBT) with standard two-dimensional full-field digital mammography (FFDM), versus FFDM alone in detecting cancer.

2Treatment groups

Experimental Treatment

Active Control

Group I: Tomosynthesis + FFDMExperimental Treatment1 Intervention

Women enrolled to DBT Arm will undergo manufacturer-defined DBT

Group II: FFDM - Standard of Care for ScreeningActive Control1 Intervention

Women enrolled to the FFDM Arm will undergo bilateral digital mammogram with standard CC and MLO views acquired