Tomosynthesis Mammographic Imaging Screening Trial

NCT02616432 · tracked via the Priya Life Science Canada tracker

Sponsor

Sunnybrook Health Sciences Centre

Phase

Not applicable

Started

2014-10

Last updated

2025-05-21

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Tomosynthesis

Tomosynthesis: Three-dimensional imaging of both breasts in standard CC and MLO views

Study 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.

Eligibility

Sex

FEMALE

Min age

40 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison — 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.

Trial sites (4)

Facility	City	Region
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

More Sunnybrook Health Sciences Centre trials in Canada

InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression Recruiting

Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection Recruiting

Evaluation of Intercostal Neuralgia in Patients With Chest Tube Insertion After Traumatic Rib Fracture Recruiting

A Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients Active, not recruiting

Topical Betamethasone Versus Moisturizer in Preventing Radiation Dermatitis in Large-Breasted Patients Treated in the Prone Position Recruiting

Other trials for the same condition

Stereotactic Body Radiation Therapy for Breast Cancer Active, not recruiting

Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host Recruiting

Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer Active, not recruiting

A Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients Active, not recruiting

Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02616432 on ClinicalTrials.gov ↗ ← All trials in Canada