Breast Density
Conditions
Keywords
Tomography, Mammography, Breast Neoplasms, Prevention and Control
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURE2D Mammogram
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.
PROCEDURETomosynthesis
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.
Sponsors
Hologic, Inc.
AHS Cancer Control Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Females 40-69 years of age attending Screen Test Kingsway referred for a screening mammogram as defined by Canadian Cancer Society guidelines. * Prior mammogram report indicating ≥ 25% breast density.
Exclusion criteria
* Prior mammogram report indicating \<25% breast density. * Breast implants * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interpretation Time of Scan | Within 1 month of receiving scan |
Secondary
| Measure | Time frame |
|---|---|
| Recall Rates | 6 month intervals for 2 years after initial scan |
| Discomfort Scale | Immediately after the subject receives scan |
Countries
Canada
Outcome results
None listed