Clinical trial NCT03587259: Innovation in Mammography: Tomosynthesis Pathways
Official title: Innovation in Mammography: Tomosynthesis Pathways
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer screening
tomosynthesis
digital mammography
Lead sponsor: Cancer Prevention and Research Institute, Italy
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 6000
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the cumulative incidence of advanced screen-detected cancers (T2 +) and the cumulative incidence of advanced interval cancers (T2 +)
timeFrame: three years
Secondary outcomes:
measure: recall rate
timeFrame: two years
measure: detection rate
timeFrame: two years
measure: benign biopsies rate
timeFrame: two years
measure: cost analysis
timeFrame: two years
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: South-Est Local Health Unit
city: Florence
country: Italy
facility: Oncological Network, Prevention and Research Institute
Study officials:
affiliation: Oncological Network, Prevention and Research Institute
name: Paola Mantellini, MDr
role: PRINCIPAL_INVESTIGATOR
References:
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