Tomosynthesis Mammographic 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 : November 12, 2021
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|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 2024|
|Estimated Study Completion Date :||November 2024|
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.
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|Ages Eligible for Study:||40 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
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|
|Responsible Party:||Dr. Roberta Jong, Principal Investigator, Sunnybrook Health Sciences Centre|
|Other Study ID Numbers:||
410000662 ( Other Grant/Funding Number: Canadian Breast Cancer Foundation )
|First Posted:||November 27, 2015 Key Record Dates|
|Last Update Posted:||November 12, 2021|
|Last Verified:||November 2021|
|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.|
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Access Criteria:||ECOG/ACRIN Sharing Access policy|
Digital Breast Tomosynthesis (DBT)
Full-field digital mammography