Screening for Breast Cancer With Digital Breast Tomosynthesis

Study Overview
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Brief Summary
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Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.

Detailed Description
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The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49). Women will be asked for informed consent when they attend the mammography. I they accept they will be randomised to one of the two arms. All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.

Official Title
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Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Digital Breast Tomosynthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45-70 years old women invited to breast cancer screening program who accepted to participate Exclusion Criteria: previous breast cancer diagnosis pregnancy or suspicion of pregnancy presence of BRCA1/2 gene mutation Previous Digital Breast Tomosynthesis performed unable to understand informed consent chemotherapy in progress presence of breast implant

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Digital Breast Tomosynthesis<br>to the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis | Device: Digital Breast Tomosynthesis<br>* twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis<br>|
| No Intervention: standard mammography<br>to the control arm the usual 2D standard mammography exam will be offered | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative incidence of T2+ cancers after screening |  | 2 years | 
| incidence of interval cancers |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate |  | 2 years | 
| recall rate |  | baseline | 
| Positive Predictive value |  | baseline | 
| diagnostic agreement between tomosynthesis and 2d mammography |  | baseline | 
| Detection rate of in situ ductal carcinoma |  | 2 years | 
| biopsy rate |  | baseline | 
| self-reported pain and discomfort during mammography |  | baseline | 
| x-ray dose |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tomosynthesis,sensitivity,specificity,screening,mammography