NCT02698202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26,877

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 19, 2025

Status Verified

June 1, 2025

Enrollment Period

3.4 years

First QC Date

February 26, 2016

Last Update Submit

December 15, 2025

Conditions

Breast Cancer

Keywords

Tomosynthesis,sensitivity,specificity,screening,mammography

Outcome Measures

Primary Outcomes (2)

  • cumulative incidence of T2+ cancers after screening

    2 years

  • incidence of interval cancers

    2 years

Secondary Outcomes (8)

  • Detection rate

    2 years

  • recall rate

    baseline

  • Positive Predictive value

    baseline

  • diagnostic agreement between tomosynthesis and 2d mammography

    baseline

  • Detection rate of in situ ductal carcinoma

    2 years

  • +3 more secondary outcomes

Study Arms (2)

Digital Breast Tomosynthesis

EXPERIMENTAL

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

Device: Digital Breast Tomosynthesis

standard mammography

NO INTERVENTION

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

Interventions

Digital Breast TomosynthesisDEVICE

twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis

Digital Breast Tomosynthesis

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old women invited to breast cancer screening program who accepted to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Sanitaria Locale Reggio Emilia

Reggio Emilia, Italy

Location

Related Publications (1)

  • Pattacini P, Nitrosi A, Giorgi Rossi P, Duffy SW, Iotti V, Ginocchi V, Ravaioli S, Vacondio R, Mancuso P, Ragazzi M, Campari C; RETomo Working Group. A Randomized Trial Comparing Breast Cancer Incidence and Interval Cancers after Tomosynthesis Plus Mammography versus Mammography Alone. Radiology. 2022 May;303(2):256-266. doi: 10.1148/radiol.211132. Epub 2022 Feb 1.

    PMID: 35103537DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Pierpaolo Pattacini, MD

    Inter-Institutional Imaging Department, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 3, 2016

Study Start

March 10, 2014

Primary Completion

July 31, 2017

Study Completion

December 31, 2019

Last Updated

December 19, 2025

Record last verified: 2025-06

Locations

IT(1)