Clinical trial NCT02835625: The Digital Breast Tomosynthesis Trial in Bergen
Official title: Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Diagnostic Imaging
Mammography
Randomized Controlled Trial
Tomosynthesis
Early performance measures
Recall
Radiation dose
Cancer detection
Sensitivity
Specificity
Cost
Economy
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
name: University of Oslo
name: The Research Council of Norway
First posted: 2016-07-18
Enrollment: 29453
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: DBT is a new screening tool, argued to be better than standard DM. This statement is based on a lower recall rate, and a higher rate of early-stage screen-detected cancer. No studies have so far reported results from women screened with DBT from GE Healthcare, as far as the investigators know. DBT from GE offer synthetic two-dimensional DM generated from the DBT data (SM), and studies have shown similar detection rates for this technique as of adjacent DM. By comparing results of early performance measures and economic aspects in two comparable populations of women in the same age group, residing in the same county, the investigators can measure the effect of SM+DBT versus standard DM with equipment from GE Healthcare. The populations will be examined by the same radiographers, screen-read by the same radiologists, histologically breast cancer proven by the same pathologists, and treated by the same surgeons and oncologists.

A prospective cohort study targeting 45,000 women invited to breast cancer screening in Bergen, Hordaland in the study period, 2016-2018, will be performed. A screening participation of approximately 75% is expected. All attending women will be asked if they are willing to participate in the study after receiving written and oral information about the study. Women willing to participate in the study will sign an informed consent. Of the attending women it is expected that about 90-95% will consent to participate in the study. The women will be randomized into two groups, a study group and a control group. The randomization will take place at the screening unit in Bergen. The outcome of the randomization is based on the 11-digit personal identification number assigned to every citizen in Norway. In the study group, the women will be screened with SM+DBT. In the control group, the women will be screened with DM. Women not willing to participate in the study will be screened with DM, and not included in our study.

The investigators aim to address the following topics and research questions:

* Study 1: Early performance measures in a population based screening program using SM+DBT versus DM - interim analyses.
* Study 2: Use of SM+DBT versus DM in a population based screening program - a randomized controlled trial.
* Study 3: Prognostic and predictive histopathologic characteristics of breast tumors detected in a population based program using SM+DBT versus DM.
* Study 4: SM+DBT and DM in a populations based screening program - which technology has the highest sensitivity for women with mammographic dense breast?
* Study 5 and 6: Costs of SM+DBT and DM in a populations based screening program - is SM+DBT cost-effective?

Eligibility criteria: Inclusion Criteria:

* Informed consent

Exclusion Criteria:

* Breast implants

Primary outcomes:
measure: Number of Participants With Screen-Detected Breast Cancer
timeFrame: 36 months from start up of the trial
Secondary outcomes:
measure: Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment
timeFrame: 36 months from start up of the trial
measure: Number of Participants Recalled for Further Assesment Due to Mammographic Findings
timeFrame: 36 months from start up of the trial
measure: Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography
timeFrame: 36 months from start up of the trial
measure: Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
timeFrame: 36 months from start up of the trial
measure: Number of Participants With Interval Breast Cancer
timeFrame: 60 months from start up of the trial
Other outcomes:
measure: Time Spent on Screen-Reading and Consensus Meetings
timeFrame: 24 months from start up of the trial
measure: Mammographic Features of Screen-Detected Breast Cancer
timeFrame: 36 months from start up of the trial
measure: Radiation Doses When Screening With Tomosynthesis Versus Digital Mammography
timeFrame: 24 months from start up of the trial
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Hordaland
city: Oslo
country: Norway
facility: Cancer Registry of Norway
Study officials:
affiliation: Norwegian Institute of Public Health
name: Solveig Hofvind, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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