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Tomosynthesis in the Oslo Breast Cancer Screening Program

NCT01248546 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25000

Last updated 2013-02-05

No results posted yet for this study

Summary

The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include women aged 50 to 69 years invited to the population-based mammography-screening program. All women attending the screening unit will be asked if they want to attend the trial. If so, they will be informed about the project, the technique, and the additional compression and radiation dose. All mammographic examinations of women attending the trial will be independently interpreted by four radiologists. Since the trial is part of the official Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be carried out on-line into the national screening database of the NBCSP. The study will include independent reading of conventional digital (2D) mammograms, 2D plus computer-aided detection (CAD), 2D plus DBT, and synthetic 2D plus DBT. There will be a common consensus meeting for all examinations having a positive score. Recalls and diagnostic work-up will be according to daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP.

Outcome measures will use performance indicators for organized screening programs, including recall rate, false positive scores, cancer detection rate, positive predictive values, and cancer characteristics for the individual readers of the trial.

Conditions

  • Recall Rate
  • Cancer Detection Rate
  • False Positive Rate
  • Positive Predictive Value

Interventions

PROCEDURE

Digital breast tomosynthesis

The participants included in the trial will have an additional radiation exposure for breast tomosynthesis

Sponsors & Collaborators

  • Norwegian Institute of Public Health

    collaborator OTHER_GOV

  • Hologic, Inc.

    collaborator INDUSTRY

  • Oslo University Hospital

    lead OTHER

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-12-31
Completion
2015-09-30

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 NCT01248546 on ClinicalTrials.gov