Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 410000662 | Other Grant/Funding Number | Canadian Breast Cancer Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eastern Cooperative Oncology Group | NETWORK |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tomosynthesis + FFDM | Experimental | Women enrolled to DBT Arm will undergo manufacturer-defined DBT |
|
| FFDM - Standard of Care for Screening | No Intervention | Women enrolled to the FFDM Arm will undergo bilateral digital mammogram with standard CC and MLO views acquired |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tomosynthesis | Device | Three-dimensional imaging of both breasts in standard CC and MLO views |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison | 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. | 3 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Recall Rates | To compare the recall rates due to abnormal screening examinations for DBT versus FFDM when used for breast cancer screening. | 3 year |
| Interval Cancers | To compare the number of interval cancers missed with DBT versus FFDM use in breast cancer screening. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Female
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roberta A Jong, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| X-Ray 505 (Under the BCCA Screening Mammography Program of BC) | Vancouver | British Columbia | V5Z 1H4 | Canada | ||
ECOG/ACRIN TMIST will collect all data when accrual starts for that trial.
Immediate
ECOG/ACRIN Sharing Access policy
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008327 | Mammography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 year |
| Prevalence of Breast Cancer Subtypes | 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. | 3 year |
| Clinical Characteristics of Cancers | 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. | 3 year |
| Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison | 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. | 4 year |
| Biomarker Correlation | Biomarker correlation to characterize disease in the tumor and compare to the tissue immediately adjacent to it. | 2 year |
| Breast Health Centre at BC Women's Hospital + Health Centre |
| Vancouver |
| British Columbia |
| V6H 3N1 |
| Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| D017437 |
| Skin and Connective Tissue Diseases |