Tomosynthesis in Screening Mammography

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography

Conditions
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Breast Density >25%

Intervention / Treatment
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* Procedure: 2D Mammogram
* Procedure: Tomosynthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A: routine 2D mammogram<br>Subject receives regular 2D mammogram. | Procedure: 2D Mammogram<br>* 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.<br>|
| Active Comparator: B: Routine Mammogram + tomosynthesis<br>Routine Mammogram and tomosynthesis | Procedure: Tomosynthesis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interpretation Time of Scan |  | Within 1 month of receiving scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall Rates |  | 6 month intervals for 2 years after initial scan | 
| Discomfort Scale |  | Immediately after the subject receives scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tomography, Mammography, Breast Neoplasms, Prevention and Control