NCT01248546

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

2.1 years

First QC Date

November 24, 2010

Last Update Submit

February 4, 2013

Conditions

Recall RateCancer Detection RateFalse Positive RatePositive Predictive Value

Keywords

Breast cancerComputer-aided detectionMammography screeningDigital breast tomosynthesis

Outcome Measures

Primary Outcomes (1)

  • Screening performance indicators

    From Nov. 22, 2010 to Dec. 31, 2012

Secondary Outcomes (1)

  • Interval cancer rate

    From Nov. 23, 2010 to Dec. 31, 2014

Study Arms (1)

Digital mammography

Procedure: Digital breast tomosynthesis

Interventions

Digital breast tomosynthesisPROCEDURE

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

Digital mammography

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women aged 50 to 69 years attending the national breast cancer screening program who sign an informed consent regarding participation in the trial

You may qualify if:

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

You may not qualify if:

  • Women with pacemaker, implants, and severely disabled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Ulleval

Oslo, Oslo County, 0407, Norway

Location

Related Publications (2)

  • Skaane P, Sebuodegard S, Bandos AI, Gur D, Osteras BH, Gullien R, Hofvind S. Performance of breast cancer screening using digital breast tomosynthesis: results from the prospective population-based Oslo Tomosynthesis Screening Trial. Breast Cancer Res Treat. 2018 Jun;169(3):489-496. doi: 10.1007/s10549-018-4705-2. Epub 2018 Feb 10.

    PMID: 29429017DERIVED

  • Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7.

    PMID: 23297332DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor dr. med.

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 25, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2012

Study Completion

September 1, 2015

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

NO(1)