NCT02698202

Screening for Breast Cancer With Digital Breast Tomosynthesis

Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26,877 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Digital Breast Tomosynthesis	twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis

Timeline

• Start date: 2014-03-10
• Primary completion: 2017-07-31
• Completion: 2019-12-31
• First posted: 2016-03-03
• Last updated: 2025-12-19

Locations

1 site across 1 country: Italy