Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02616432

Tomosynthesis Mammographic Imaging Screening 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Breast Health Centre at BC Women's Hospital + Health Centre, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tomosynthesis

Device

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

Primary outcomes

  1. 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

  1. Recall Rates

    Time frame: 3 year

    To compare the recall rates due to abnormal screening examinations for DBT versus FFDM when used for breast cancer screening.

  2. Interval Cancers

    Time frame: 3 year

    To compare the number of interval cancers missed with DBT versus FFDM use in breast cancer screening.

  3. Prevalence of Breast Cancer Subtypes

    Time frame: 3 year

    To estimate the prevalence of breast cancer subtypes (Luminal A, Luminal B, HER2neu, Basal-like, Claudin-low) by DBT and FFDM, stratified on whether cancers were detected in screening or as interval cancers.

  4. Clinical Characteristics of Cancers

    Time frame: 3 year

    To assess and compare clinical characteristics (e.g. stage, grade, ER, PR, and HER2status) of cancers detected from screening by DBT and FFDM. Approximately 75 genes will be assayed in tumors detected in each arm of the study to evaluate breast cancer molecular subtype.

  5. Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison

    Time frame: 4 year

    To assess different combinations of FFDM, tomosynthesis and synthesized FFDM images in reader studies to assist in determining the optimum balance between radiation exposure and technique. AUC of ROC curves will be used to compare combinations. A panel of radiologists will read the various combinations of images in random order to assess whether tomosynthesis with synthetic 2D images is as accurate as tomosynthesis with FFDM images. The latter will require more radiation exposure.

  6. Biomarker Correlation

    Time frame: 2 year

    Biomarker correlation to characterize disease in the tumor and compare to the tissue immediately adjacent to it.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Eastern Cooperative Oncology Group

Registry information

Official study title

Tomosynthesis Mammography Imaging Screening Trial Lead-in

Acronym: TMISTLead-in

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Nov 27, 2015
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.