Tomosynthesis Mammographic Imaging Screening Trial

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Device: Tomosynthesis

• Registration Number: NCT02616432
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 3065

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tomosynthesis + FFDM	Tomosynthesis	Women enrolled to DBT Arm will undergo manufacturer-defined DBT

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison	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

Name	Time	Method
Recall Rates	3 year	To compare the recall rates due to abnormal screening examinations for DBT versus FFDM when used for breast cancer screening.
Interval Cancers	3 year	To compare the number of interval cancers missed with DBT versus FFDM use in breast cancer screening.
Prevalence of Breast Cancer Subtypes	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.
Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison	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	2 year	Biomarker correlation to characterize disease in the tumor and compare to the tissue immediately adjacent to it.
Clinical Characteristics of Cancers	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.

Trial Locations

Locations (4)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

X-Ray 505 (Under the BCCA Screening Mammography Program of BC); 🇨🇦 Vancouver, British Columbia, Canada

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