Trial Outcomes & Findings for The Digital Breast Tomosynthesis Trial in Bergen (NCT NCT02835625)
NCT ID: NCT02835625
Last Updated: 2024-08-28
Results Overview
Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29453 participants
Primary outcome timeframe
36 months from start up of the trial
Results posted on
2024-08-28
Participant Flow
Women were invited to participate when attending screening at the screening unit Danmarksplass in Bergen, Norway. The recruitment period lasted from January 14th 2016 to December 15th 2017.
Women that attended screening but had breast implant were not invited to participate, and thus not randomized to either of the study groups.
Participant milestones
| Measure |
Digital Breast Tomosynthesis
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 Mammography
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14734
|
14719
|
|
Overall Study
COMPLETED
|
14734
|
14719
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Digital Breast Tomosynthesis
n=14380 Participants
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 Mammography
n=14369 Participants
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.
|
Total
n=28749 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<55 years
|
3746 Participants
n=14380 Participants
|
3813 Participants
n=14369 Participants
|
7559 Participants
n=28749 Participants
|
|
Age, Customized
55-59 years
|
3628 Participants
n=14380 Participants
|
3668 Participants
n=14369 Participants
|
7296 Participants
n=28749 Participants
|
|
Age, Customized
60-64 years
|
3625 Participants
n=14380 Participants
|
3492 Participants
n=14369 Participants
|
7117 Participants
n=28749 Participants
|
|
Age, Customized
>64 years
|
3381 Participants
n=14380 Participants
|
3396 Participants
n=14369 Participants
|
6777 Participants
n=28749 Participants
|
|
Sex: Female, Male
Female
|
14380 Participants
n=14380 Participants
|
14369 Participants
n=14369 Participants
|
28749 Participants
n=28749 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14380 Participants
|
0 Participants
n=14369 Participants
|
0 Participants
n=28749 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Norway
|
14380 participants
n=14380 Participants
|
14369 participants
n=14369 Participants
|
28749 participants
n=28749 Participants
|
|
Screening history
Prevalent (first screening)
|
2013 Participants
n=14380 Participants
|
2053 Participants
n=14369 Participants
|
4066 Participants
n=28749 Participants
|
|
Screening history
Subsequent
|
12367 Participants
n=14380 Participants
|
12316 Participants
n=14369 Participants
|
24683 Participants
n=28749 Participants
|
PRIMARY outcome
Timeframe: 36 months from start up of the trialComparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.
Outcome measures
| Measure |
Digital Breast Tomosynthesis
n=14380 Participants
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 Mammography
n=14369 Participants
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.
|
|---|---|---|
|
Number of Participants With Screen-Detected Breast Cancer
|
95 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: 36 months from start up of the trialPositive 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.
Outcome measures
| Measure |
Digital Breast Tomosynthesis
n=444 Participants
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 Mammography
n=571 Participants
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.
|
|---|---|---|
|
Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment
|
95 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: 36 months from start up of the trialComparison of rate of recall for further assesment due to mammographic findings in tomosynthesis versus digital mammography as performed in a population based screening program.
Outcome measures
| Measure |
Digital Breast Tomosynthesis
n=14380 Participants
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 Mammography
n=14369 Participants
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.
|
|---|---|---|
|
Number of Participants Recalled for Further Assesment Due to Mammographic Findings
|
444 Participants
|
571 Participants
|
SECONDARY outcome
Timeframe: 36 months from start up of the trialPopulation: 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.
The incremental cost per woman screened with digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening program.
Outcome measures
| Measure |
Digital Breast Tomosynthesis
n=29453 Participants
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 Mammography
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.
|
|---|---|---|
|
Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography
Incremental costs of DBT vs. DM in Euro
|
8.5 €
Interval 8.4 to 8.6
|
—
|
|
Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography
Incremental cost of DBT vs. DM after adding costs of recall, in Euro
|
6.2 €
Interval 4.6 to 7.9
|
—
|
SECONDARY outcome
Timeframe: 36 months from start up of the trialPopulation: When collecting information on histopathological tumor characteristics, not all participants had information available on all variables.
Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.
Outcome measures
| Measure |
Digital Breast Tomosynthesis
n=80 Participants
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 Mammography
n=71 Participants
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.
|
|---|---|---|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Histological type : Carcinoma (no special type)
|
62 Participants
|
51 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Histological type : Lobular carcinoma
|
6 Participants
|
13 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Histological type : Tubular carcinoma
|
2 Participants
|
4 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Histological type : Other carcinoma
|
10 Participants
|
3 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Tumor diameter : <10 mm
|
10 Participants
|
18 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Tumor diameter : >=10-<20 mm
|
43 Participants
|
29 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Tumor diameter : >=20 mm
|
17 Participants
|
13 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Lymph node positive
|
14 Participants
|
18 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Histological grade : grade 1
|
22 Participants
|
24 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Histological grade : grade 2
|
38 Participants
|
35 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Histological grade : grade 3
|
16 Participants
|
10 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Estrogen receptor positive
|
71 Participants
|
69 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Progesterone receptor positive
|
61 Participants
|
62 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
HER2 positive
|
8 Participants
|
8 Participants
|
|
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Ki67 >=30%
|
21 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 60 months from start up of the trialRate of interval breast cancer among those screened with tomosynthesis versus digital mammography as performed in a population based screening program.
Outcome measures
| Measure |
Digital Breast Tomosynthesis
n=14380 Participants
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 Mammography
n=14369 Participants
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.
|
|---|---|---|
|
Number of Participants With Interval Breast Cancer
|
20 Participants
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months from start up of the trialPopulation: 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.
The time spent on screen-reading and consensus will be compared for tomosynthesis versus digital mammography
Outcome measures
| Measure |
Digital Breast Tomosynthesis
n=7037 Participants
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 Mammography
n=7052 Participants
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.
|
|---|---|---|
|
Time Spent on Screen-Reading and Consensus Meetings
Initial screen reading
|
70.5 seconds
Standard Deviation 54.4
|
41.3 seconds
Standard Deviation 49.6
|
|
Time Spent on Screen-Reading and Consensus Meetings
Consensus reading
|
192.1 seconds
Standard Deviation 118.1
|
131.9 seconds
Standard Deviation 79.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 months from start up of the trialDistribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.
Outcome measures
| Measure |
Digital Breast Tomosynthesis
n=95 Participants
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 Mammography
n=87 Participants
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.
|
|---|---|---|
|
Mammographic Features of Screen-Detected Breast Cancer
Spiculated mass
|
35 Participants
|
16 Participants
|
|
Mammographic Features of Screen-Detected Breast Cancer
Indistinct mass
|
16 Participants
|
16 Participants
|
|
Mammographic Features of Screen-Detected Breast Cancer
Calcifications
|
13 Participants
|
20 Participants
|
|
Mammographic Features of Screen-Detected Breast Cancer
Architectural distortion
|
10 Participants
|
7 Participants
|
|
Mammographic Features of Screen-Detected Breast Cancer
Asymmetry
|
7 Participants
|
12 Participants
|
|
Mammographic Features of Screen-Detected Breast Cancer
Mass with calcifications
|
7 Participants
|
11 Participants
|
|
Mammographic Features of Screen-Detected Breast Cancer
Obscured mass
|
1 Participants
|
3 Participants
|
|
Mammographic Features of Screen-Detected Breast Cancer
Associated features
|
1 Participants
|
0 Participants
|
|
Mammographic Features of Screen-Detected Breast Cancer
Circumscribed mass
|
5 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months from start up of the trialPopulation: Interim analysis performed on study population from the first year of the trial (2016). Not all women had available information on radiation dose.
Radiation doses will be measured for screening with tomosynthesis and digital mammography by an automated software, in milligray (mGy).
Outcome measures
| Measure |
Digital Breast Tomosynthesis
n=6957 Participants
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 Mammography
n=6972 Participants
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.
|
|---|---|---|
|
Radiation Doses When Screening With Tomosynthesis Versus Digital Mammography
|
2.96 mGy
Standard Deviation 0.62
|
2.95 mGy
Standard Deviation 0.38
|
Adverse Events
Digital Breast Tomosynthesis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Digital Mammography
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place