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The Digital Breast Tomosynthesis Trial in Bergen

NCT02835625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29453

Last updated 2024-08-28

Study results available
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Summary

Compare synthetic mammography+digital breast tomosynthesis (SM+DBT) with digital mammography (DM) as a screening tool for women aged 50-69 years, invited to participate in the Norwegian Breast Cancer Screening Program at the screening unit in Bergen, Norway, with regard to early performance measures, including prognostic and predictive tumor characteristics, radiation doses and cost-effectiveness.

Conditions

  • Breast Neoplasms

Interventions

RADIATION

Synthetic Mammography + Digital Breast Tomosynthesis

Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.

RADIATION

Digital mammography

Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • The Research Council of Norway

    collaborator OTHER

  • Norwegian Institute of Public Health

    lead OTHER_GOV

Principal Investigators

  • Solveig Hofvind, Professor · Norwegian Institute of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
48 Years
Max Age
71 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-06-30
Completion
2021-05-31

Countries

  • Norway

Study Locations

More Related Trials

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 NCT02835625 on ClinicalTrials.gov