Trial record 1 of 203492 for:    ALL
Previous Study | Return to List | Next Study

Tomosynthesis Mammography Imaging Screening Trial (TMISTLead-in)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Sunnybrook Health Sciences Centre
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Dr. Roberta Jong, Sunnybrook Health Sciences Centre Identifier:
First received: November 10, 2015
Last updated: November 24, 2015
Last verified: November 2015
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.

Condition Intervention
Breast Cancer
Device: Tomosynthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Tomosynthesis Mammography Imaging Screening Trial Lead-in

Resource links provided by NLM:

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison [ Time Frame: 3 year follow-up ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Recall Rates [ Time Frame: 3 year ] [ Designated as safety issue: No ]
    To compare the recall rates due to abnormal screening examinations for DBT versus FFDM when used for breast cancer screening.

  • Interval Cancers [ Time Frame: 3 year ] [ Designated as safety issue: No ]
    To compare the number of interval cancers missed with DBT versus FFDM use in breast cancer screening.

  • Prevalence of Breast Cancer Subtypes [ Time Frame: 3 year ] [ Designated as safety issue: No ]
    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.

  • Clinical Characteristics of Cancers [ Time Frame: 3 year ] [ Designated as safety issue: No ]
    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.

  • Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison [ Time Frame: 4 year ] [ Designated as safety issue: No ]
    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.

  • Biomarker Correlation [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    Biomarker correlation to characterize disease in the tumor and compare to the tissue immediately adjacent to it.

Estimated Enrollment: 2118
Study Start Date: October 2014
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02616432

Contact: Roberta A Jong, MD 416 480 4355
Contact: Anoma Gunasekara, B.Sc 416 480 5786

Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Anoma Gunasekara, BSc    416 480 5786   
Contact: Gordon E Mawdsley, B Sc    416 480 5724   
Principal Investigator: Roberta A Jong, MD         
Sub-Investigator: Martin J Yaffe, PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Eastern Cooperative Oncology Group
Principal Investigator: Roberta A Jong, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Roberta Jong, Principal Investigator, Sunnybrook Health Sciences Centre Identifier: NCT02616432     History of Changes
Other Study ID Numbers: 001-2014b, 410000662
Study First Received: November 10, 2015
Last Updated: November 24, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Digital Breast Tomosynthesis (DBT)
Breast Imaging
Full-field digital mammography
Breast screening processed this record on November 27, 2015