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Tomosynthesis as Primary Test for Breast Cancer Screening

NCT04461808 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10156

Last updated 2025-06-25

No results posted yet for this study

Summary

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

Conditions

Interventions

DIAGNOSTIC_TEST

tomosynthesis + synthetic 2D

Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

DIAGNOSTIC_TEST

digital mammography

Women will be screened for one round digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Sponsors & Collaborators

  • AULSS 9 Scaligera di Verona

    collaborator UNKNOWN

  • IRCCS Policlinico S. Donato, Milano

    collaborator UNKNOWN

  • Azienda Ospedaliera Universitaria Integrata Verona

    collaborator OTHER

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2027-04-30
Completion
2029-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04461808 on ClinicalTrials.gov