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Tomosynthesis in the Oslo Breast Cancer Screening Program

Digital Breast Tomosynthesis in the Oslo Mammography Screening Program

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01248546
Acronym
DBT
Enrollment
25000
Registered
2010-11-25
Start date
2010-11-30
Completion date
2015-09-30
Last updated
2013-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Breast cancer, Computer-aided detection, Mammography screening, Digital breast tomosynthesis

Brief 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.

Interventions

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

Sponsors

Norwegian Institute of Public Health
CollaboratorOTHER_GOV
Hologic, Inc.
CollaboratorINDUSTRY
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 69 Years
Healthy volunteers
Yes

Inclusion criteria

* Women 50 to 69 years who have signed the informed consent

Exclusion criteria

* Women with pacemaker, implants, and severely disabled

Design outcomes

Primary

MeasureTime frame
Screening performance indicatorsFrom Nov. 22, 2010 to Dec. 31, 2012

Secondary

MeasureTime frame
Interval cancer rateFrom Nov. 23, 2010 to Dec. 31, 2014

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026