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| ID | Type | Description | Link |
|---|---|---|---|
| DX-TOM-001 25232 |
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| Name | Class |
|---|---|
| Hologic, Inc. | INDUSTRY |
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Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.
We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped < 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: routine 2D mammogram | Active Comparator | Subject receives regular 2D mammogram. |
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| B: Routine Mammogram + tomosynthesis | Active Comparator | Routine Mammogram and tomosynthesis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2D Mammogram | Procedure | Those patients randomized to the mammogram arm will receive a regular 2D mammogram. Compression lasts several seconds in order to obtain 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast. |
| Measure | Description | Time Frame |
|---|---|---|
| Interpretation Time of Scan | Within 1 month of receiving scan |
| Measure | Description | Time Frame |
|---|---|---|
| Recall Rates | 6 month intervals for 2 years after initial scan | |
| Discomfort Scale | Immediately after the subject receives scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aalo Bistritz, MD | Cross Cancer Institute | Study Chair |
| Aalo Bistritz, MD | Cross Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Screen Test | Edmonton | Alberta | Canada |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Tomosynthesis | Procedure | Those patients randomized to the tomosynthesis arm will receive a combination of 3D and 2D screening mammogram. The additional tomosynthesis data is obtained immediately after acquisition of the 2D study, with the patient and breast remaining in the same position and compression. Compression lasts about 7 seconds longer for each of the 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast. |
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| D017437 |
| Skin and Connective Tissue Diseases |