Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Immune System Diseases

Breast Neoplasms

Hypersensitivity

Breast Diseases

Skin Diseases

Synthetic Mammography (SM) + Digital Breast Tomosynthesis (DBT)

The SM+DBT will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not.

Women selected for further assessment (positive screening exam) will be recalled.

The digital mammograms will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not.

Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.

Synthetic Mammography + Digital Breast Tomosynthesis

Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.

Digital mammography

Solveig Hofvind, Professor

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.

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?

The Digital Breast Tomosynthesis Trial in Bergen

Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?

We will not share the data outside the project group

The time spent on screen-reading and consensus will be compared for tomosynthesis versus digital mammography

Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.

Radiation doses will be measured for screening with tomosynthesis and digital mammography by an automated software, in milligray (mGy).

Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.

Positive predictive value of recalls (number of screen-detected breast cancer among participants recalled for further assesment) for tomosynthesis versus digital mammography in a population based screening program.

Comparison of rate of recall for further assesment due to mammographic findings in tomosynthesis versus digital mammography as performed in a population based screening program.

The incremental cost per woman screened with digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening program.

Rate of interval breast cancer among those screened with tomosynthesis versus digital mammography as performed in a population based screening program.

Haukeland University Hospital

University of Oslo

The Research Council of Norway

Cancer Registry of Norway

Digital Breast Tomosynthesis + Synthetic Mammography (DBT)

The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.

Women selected for further assessment (positive screening exam) was recalled.

Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.

Digital Breast Tomosynthesis

The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.

Women selected for further assessment (positive screening exam) was recalled.

Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.

Digital Mammography

Total

<55 years

55-59 years

60-64 years

>64 years

Age, Customized

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Norway

Region of Enrollment

Prevalent (first screening)

Subsequent

Screening history

We excluded women with previous breast cancer (DBT = 314, DM = 316), women with breast symptoms at screening (DBT = 39, DM = 34) and one woman with metastasis from melanoma (DBT).

Prof. Solveig Hofvind

Number of Participants With Screen-Detected Breast Cancer

Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment

Number of Participants Recalled for Further Assesment Due to Mammographic Findings

Incremental costs of DBT vs. DM in Euro

Incremental cost of DBT vs. DM after adding costs of recall, in Euro

Comparing costs of procedure use and screening, recall and treatment costs estimated at the individual level for Digital Breast Tomosynthesis + Synthetic Mammography (DBT) versus Digital Mammography (DM).

Digital Breast Tomosynthesis Versus Digital Mammography

For each participant, the incremental cost of tomosynthesis vs. digital mammography were estimated, not the total cost of tomosynthesis vs. digital mammography. The investigators assumed that costs not pertaining to examination and reading times, mammograph price, IT storage and connectivity were equal for the two. This Outcome Measure was pre-specified to present the incremental costs per screened woman. By nature, incremental costs are calculated between groups.

Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography

Histological type : Carcinoma (no special type)

Histological type : Lobular carcinoma

Histological type : Tubular carcinoma

Histological type : Other carcinoma

Tumor diameter : <10 mm

Tumor diameter : >=10-<20 mm

Tumor diameter : >=20 mm

Lymph node positive

Histological grade : grade 1

Histological grade : grade 2

Histological grade : grade 3

Estrogen receptor positive

Progesterone receptor positive

HER2 positive

Ki67 >=30%

When collecting information on histopathological tumor characteristics, not all participants had information available on all variables.

Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer

Number of Participants With Interval Breast Cancer

Initial screen reading

Consensus reading

Interim analysis performed on study population from the first year of the trial (2016). All cases were screen-read by two radiologist, however not all were discussed at consensus.

Time Spent on Screen-Reading and Consensus Meetings

Mammographic Features of Screen-Detected Breast Cancer

Interim analysis performed on study population from the first year of the trial (2016). Not all women had available information on radiation dose.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Digital Breast Tomosynthesis Trial in Bergen	NCT02835625	Breast Neoplasm...	Synthetic Mammo... Digital mammogr...	48 Years - 71 Years	Cancer Registry of Norway
The Digital Breast Tomosynthesis Trial in Bergen	NCT02835625	Breast Neoplasm...	Synthetic Mammo... Digital mammogr...	48 Years - 71 Years	Cancer Registry of Norway

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