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 : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Tomosynthesis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tomosynthesis Mammography Imaging Screening Trial Lead-in|
|Actual Study Start Date :||October 2014|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2021|
Experimental: Tomosynthesis + FFDM
Women enrolled to DBT Arm will undergo manufacturer-defined DBT
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
- 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.
- 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.
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
|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|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Roberta A Jong, MD||Sunnybrook Health Sciences Centre|