Tomosynthesis in the Oslo Breast Cancer Screening Program

NCT ID: NCT01248546

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-09-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Digital mammography

Digital breast tomosynthesis

Intervention Type: PROCEDURE

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

Interventions

Digital breast tomosynthesis

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Women with pacemaker, implants, and severely disabled

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role: collaborator

Hologic, Inc.

INDUSTRY

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Per Skaane

professor dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital, Ulleval

Oslo, Oslo County, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 29429017 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23297332 (View on PubMed)

Other Identifiers

2010/144 (REK)

Identifier Type: -

Identifier Source: org_study_id