Screening for Breast Cancer With Digital Breast Tomosynthesis

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: Digital Breast Tomosynthesis

• Registration Number: NCT02698202
• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

Brief 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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-02-26
• Status Verified: 2016-03
• Study First Posted: 2016-03-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04
• Primary Completion: 2016-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
cumulative incidence of T2+ cancers after screening	2 years
incidence of interval cancers	2 years

Secondary Outcome Measures

Name	Time	Method
Positive Predictive value	baseline
self-reported pain and discomfort during mammography	baseline
Detection rate	2 years
recall rate	baseline
diagnostic agreement between tomosynthesis and 2d mammography	baseline
Detection rate of in situ ductal carcinoma	2 years
biopsy rate	baseline
x-ray dose	baseline

Trial Locations

Locations (1)

Azienda Sanitaria Locale Reggio Emilia; 🇮🇹 Reggio Emilia, Italy