Tomosynthesis Mammographic Imaging Screening Trial (TMISTLead-in)

April 16, 2024 updated by: Dr. Roberta Jong, Sunnybrook Health Sciences Centre

Tomosynthesis Mammography Imaging Screening Trial Lead-in

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3065

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H4
        • X-Ray 505 (Under the BCCA Screening Mammography Program of BC)
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Breast Health Centre at BC Women's Hospital + Health Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tomosynthesis + FFDM
Women enrolled to DBT Arm will undergo manufacturer-defined DBT
Device: Tomosynthesis
Three-dimensional imaging of both breasts in standard CC and MLO views
No Intervention: FFDM - Standard of Care for Screening
Women enrolled to the FFDM Arm will undergo bilateral digital mammogram with standard CC and MLO views acquired

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 year
Interval Cancers
Time Frame: 3 year
To compare the number of interval cancers missed with DBT versus FFDM use in breast cancer screening.
3 year
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.
3 year
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.
3 year
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.
4 year
Biomarker Correlation
Time Frame: 2 year
Biomarker correlation to characterize disease in the tumor and compare to the tissue immediately adjacent to it.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Eastern Cooperative Oncology Group

Investigators

  • Principal Investigator: Roberta A Jong, MD, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimated)

November 27, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 001-2014b
  • 410000662 (Other Grant/Funding Number: Canadian Breast Cancer Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

ECOG/ACRIN TMIST will collect all data when accrual starts for that trial.

IPD Sharing Time Frame

Immediate

IPD Sharing Access Criteria

ECOG/ACRIN Sharing Access policy

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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