Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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.

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.

Tomosynthesis

2D mammography is a X-ray examinations used to detect breast cancer in the screening programme.

2D mammography

Paola Mantellini, MDr

Roberto Turillazzi, MDr

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.

Innovation in Mammography: Tomosynthesis Pathways

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.

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

number of breast cancer cases (invasive and in situ forms) divided by the number of screened women (per 1,000)

number of benign biopsies divided by the total number of biopsies

an activity based cost analysis will be performed in order to obtain the real costs of DBT screening pathway.

Cancer Prevention and Research Institute, Italy

Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment

surveillance of patient already treated for breast cancer must have annual mammography

patient addressed for diagnosis of a detected anomaly

tomosynthesis

Sophie TAIEB, MD

This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)

Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

number of avoided focused cliches and ultrasound, after tomosynthesis analysis

comparison of tomosynthesis irradiation and focused cliches irradiation

number of breast cancer detected through tomosynthesis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Innovation in Mammography: Tomosynthesis Pathways	NCT03587259	Breast Cancer	Tomosynthesis 2D mammography	45 Years - 46 Years	Cancer Prevention and Research Institute, Italy
Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis	NCT01612650	Breast Cancer 2D Mammography 3D Mammography	tomosynthesis 2D mammography	40 Years -	Centre Oscar Lambret
Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis	NCT01612650	Breast Cancer 2D Mammography 3D Mammography	tomosynthesis 2D mammography	40 Years -	Centre Oscar Lambret
Innovation in Mammography: Tomosynthesis Pathways	NCT03587259	Breast Cancer	Tomosynthesis 2D mammography	45 Years - 46 Years	Cancer Prevention and Research Institute, Italy
Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis	NCT01612650	Breast Cancer 2D Mammography 3D Mammography	tomosynthesis 2D mammography	40 Years -	Centre Oscar Lambret

Spots Global Cancer Trial Database for 2d mammography