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Tomosynthesis Versus Digital Mammography in a Population-based Screening Program

NCT02590315 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92000

Last updated 2019-01-31

No results posted yet for this study

Summary

Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis (DBT) is more sensitive and more specific than conventional digital mammography (DM). However, large randomised controlled trials (RCTs) are needed to confirm these promising results. Furthermore, potential side effects of DBT in the screening setting have to be properly evaluated. In particular, the major concern is about overdiagnosis and its consequences; overdiagnosis refers to the detection of cancers at screening, which would not have become clinically apparent in the woman's lifetime.

This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome parameter will be the difference between the two tests in rates of advanced cancers detected at the subsequent round and interval cancers (within the first two years after the study screening round). Secondary outcomes measures will be diagnostic performance indicators for organised breast screening (i.e, cancer detection rate, recall rate, false positive rate, positive predictive value), parameters used in cost-effectiveness analysis, pathologic and biological characteristics of screen-detected cancers.

Conditions

Interventions

OTHER

Invitation for breast screening and random allocation

Invitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM.

DEVICE

DBT

Combo-mode DBT. DBT participants will have an additional radiation exposure for breast tomosynthesis.

DEVICE

Conventional digital mammography.

Conventional digital mammography.

Sponsors & Collaborators

  • Regione Piemonte

    collaborator OTHER

  • im3D S.p.A.

    collaborator OTHER

  • Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

    lead OTHER

Principal Investigators

  • Alfonso Frigerio, Dr · SCDO Epidemiologia dei Tumori, AOU Città della Salute e della Scienza di Torino

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
46 Years
Max Age
68 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-12-31
Completion
2021-12-31

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 NCT02590315 on ClinicalTrials.gov