Screening for Breast Cancer With Digital Breast Tomosynthesis

Azienda Unità Sanitaria Locale Reggio Emilia

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: Digital Breast Tomosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT02698202

ReTomo

Details and patient eligibility

About

Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.

Full description

The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49).

Women will be asked for informed consent when they attend the mammography. I they accept they will be randomised to one of the two arms.

All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.

Enrollment: 40,000 estimated patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

45-70 years old women invited to breast cancer screening program who accepted to participate

Exclusion criteria

• previous breast cancer diagnosis
• pregnancy or suspicion of pregnancy
• presence of BRCA1/2 gene mutation
• Previous Digital Breast Tomosynthesis performed
• unable to understand informed consent
• chemotherapy in progress
• presence of breast implant

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40,000 participants in 2 patient groups

Digital Breast Tomosynthesis

Experimental group

Description:

to the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis

Treatment:

Device: Digital Breast Tomosynthesis

standard mammography

No Intervention group

Description:

to the control arm the usual 2D standard mammography exam will be offered