Innovation in Mammography: Tomosynthesis Pathways

Study Overview
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Brief Summary
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The study aims at evaluating the introduction of tomosynthesis in mammography screening, analyzing the benefits, disadvantages and feasibility in current clinical practice. It involves women aged 45-46 that will be divided, by drawing lots, into two groups: one group will do the 2D digital mammography (control group), while the other group (intervention group) will do tomosynthesis. In the intervention group the 2D two-dimensional mammography will be reconstructed starting from tomosynthesis without exposing women to other radiation.

Detailed Description
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The IMPETO trial is a population-based, multicentre, randomised trial aimed at evaluating the clinical accuracy of Digital Breast Tomosynthesis (DBT) in adjunct to synthetic mammograms (sDM) compared to standard two-dimensional digital mammography alone (2D) in a screening programme. 45-46 year-old women resident in the screening centre catchment area of Florence and South-Est Local Health Unit are invited to attend for mammography screening and asked for informed consent to be included in the study. Women are then randomly allocated either to an usual care group (2D mammography) or to the intervention group. In the intervention group, DBT combined with sDM is proposed in order to reduce radiation exposure. The next year women of both groups will be invited to attend the usual screening examination (2D mammography). The enrolment will last 12-18 months; the whole study 36 months. The estimated sample size is 6000 women, 3000 per arm. Data will be pooled with the trial Screening for Breast Cancer With Digital Breast Tomosynthesis, ClinicalTrials.gov Identifier: NCT02698202.

Official Title
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Innovation in Mammography: Tomosynthesis Pathways

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Tomosynthesis
* Diagnostic Test: 2D mammography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45-46 years old women resident in the screening area Exclusion Criteria: previous breast cancer written refusal to participate in the screening programme pregnancy, breastfeeding presence of prostheses; ongoing chemotherapy; impossibility to submit the informed consent for linguistic problems or for inability of women to provide informed consent; verified presence of BRCA1 - BRCA2 (Breast Related Cancer Antigens 1 - Breast Related Cancer Antigens 2) genetic mutation or involvement in surveillance path for heredo-familial tumor; previous known tomosynthesis.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2D mammography<br>45-46 years old women are invited to attend the usual screening examination (2D mammography). The next year they will be invited to make a 2D mammography, according to screening protocol. | Diagnostic Test: 2D mammography<br>* 2D mammography is a X-ray examinations used to detect breast cancer in the screening programme.<br>|
| Experimental: Tomosynthesis<br>45-46 years old women are invited to attend the Digital Breast Tomosynthesis (DBT) in adjunct to synthetic mammograms (sDM). The next year they will be invited to make a 2D mammography, according to screening protocol. | Diagnostic Test: Tomosynthesis<br>* DBT is a x-ray examination that allows to visualize the breast on 3 planes (3D) and therefore to help to see lesions hardly visible to mammography due to the overlap of glandular tissue.<br>* Other names: Digital Breast Tomosynthesis (DBT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the cumulative incidence of advanced screen-detected cancers (T2 +) and the cumulative incidence of advanced interval cancers (T2 +) | number of T2+ screen-detected cancers divided by all screened women at subsequent round of screening and number of T2+ interval cancers divided by all screened women at subsequent round of screening. | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recall rate | number of women recalled to perform 2nd level assessments) for invasive tests and for non-invasive examinations in the two arms divided by the number of screened women | two years | 
| detection rate | number of breast cancer cases (invasive and in situ forms) divided by the number of screened women (per 1,000) | two years | 
| benign biopsies rate | number of benign biopsies divided by the total number of biopsies | two years | 
| cost analysis | an activity based cost analysis will be performed in order to obtain the real costs of DBT screening pathway. | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer screening, tomosynthesis, digital mammography