Breast Cancer Clinical Trial
Official title:
Innovation in Mammography: Tomosynthesis Pathways
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.
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