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Tomosynthesis Mammograpic Imaging Screening Trial (TMISTLead-in)

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ClinicalTrials.gov Identifier: NCT02616432
Recruitment Status : Active, not recruiting
First Posted : November 27, 2015
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Device: Tomosynthesis

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Tomosynthesis Mammography Imaging Screening Trial Lead-in
Actual Study Start Date : October 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616432


Locations
Canada, British Columbia
X-Ray 505 (Under the BCCA Screening Mammography Program of BC)
Vancouver, British Columbia, Canada, V5Z 1H4
Breast Health Centre at BC Women's Hospital + Health Centre
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Roberta A Jong, MD Sunnybrook Health Sciences Centre
More Information

Responsible Party: Dr. Roberta Jong, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02616432     History of Changes
Other Study ID Numbers: 001-2014b
410000662 ( Other Grant/Funding Number: Canadian Breast Cancer Foundation )
First Posted: November 27, 2015    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: ECOG/ACRIN TMIST will collect all data when accrual starts for that trial.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Immediate
Access Criteria: ECOG/ACRIN Sharing Access policy

Keywords provided by Dr. Roberta Jong, Sunnybrook Health Sciences Centre:
Tomosynthesis
Digital Breast Tomosynthesis (DBT)
Breast Imaging
Full-field digital mammography
Breast screening