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Tomosynthesis Mammographic Imaging Screening Trial (TMISTLead-in)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02616432
Recruitment Status : Active, not recruiting
First Posted : November 27, 2015
Last Update Posted : April 12, 2023
Sponsor:
Collaborator:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Dr. Roberta Jong, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE November 10, 2015
First Posted Date  ICMJE November 27, 2015
Last Update Posted Date April 12, 2023
Actual Study Start Date  ICMJE October 2014
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2015)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2015)
  • 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.
  • Interval Cancers [ Time Frame: 3 year ]
    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 ]
    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 ]
    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 ]
    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 ]
    Biomarker correlation to characterize disease in the tumor and compare to the tissue immediately adjacent to it.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tomosynthesis Mammographic Imaging Screening Trial
Official Title  ICMJE Tomosynthesis Mammography Imaging Screening Trial Lead-in
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Breast Cancer
Intervention  ICMJE Device: Tomosynthesis
Three-dimensional imaging of both breasts in standard CC and MLO views
Study Arms  ICMJE
  • Experimental: Tomosynthesis + FFDM
    Women enrolled to DBT Arm will undergo manufacturer-defined DBT
    Intervention: Device: Tomosynthesis
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 1, 2017)		 2300
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2015)		 2118
Estimated Study Completion Date  ICMJE November 2024
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02616432
Other Study ID Numbers  ICMJE 001-2014b
410000662 ( Other Grant/Funding Number: Canadian Breast Cancer Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: ECOG/ACRIN TMIST will collect all data when accrual starts for that trial.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Immediate
Access Criteria: ECOG/ACRIN Sharing Access policy
Current Responsible Party Dr. Roberta Jong, Sunnybrook Health Sciences Centre
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Eastern Cooperative Oncology Group
Investigators  ICMJE
Principal Investigator: Roberta A Jong, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP