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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
6,000
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.
2D mammography is a X-ray examinations used to detect breast cancer in the screening programme.
South-Est Local Health Unit
Arezzo, Italy
Oncological Network, Prevention and Research Institute
Florence, Italy
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.
Time frame: three years
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
Time frame: two years
detection rate
number of breast cancer cases (invasive and in situ forms) divided by the number of screened women (per 1,000)
Time frame: two years
benign biopsies rate
number of benign biopsies divided by the total number of biopsies
Time frame: two years
cost analysis
an activity based cost analysis will be performed in order to obtain the real costs of DBT screening pathway.
Time frame: two years
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