To investigate the diagnostic value of 3DUS as a standalone imaging modality as well as in combination with conventional imaging modalities to diagnose breast cancer in Dutch breast cancer screening participants with a BI-RADS 0 mammography result.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the accuracy of different imaging strategies in
diagnosing breast cancer, expressed as the area under the receiver operating
characteristic (ROC) curve. Pathology or the results of all imaging modalities
are used as the reference standard. All study participants will be followed up
to the next scheduled screening round approximately 2 years later to determine
if any breast cancer was missed. The imaging modalities under study,
supplemental to the full-field digital screening mammography, are 3DUS, digital
breast tomosynthesis (DBT) and handheld ultrasound (HHUS).
Secondary outcome
The diagnostic accuracy of the different imaging strategies among subgroups of
patients based on mammographic density and age.
The biopsy referral rate for the different imaging strategies under study.
The interobserver reliability for 3DUS.
Background summary
Population-based mammography screening has proven successful in decreasing
breast cancer mortality due to breast cancer detection and treatment at an
early stage. However, one of the main disadvantages of screening is a
false-positive test result, leading to a costly diagnostic work-up of a
non-malignant lesion, adverse psychological consequences and pressure on health
care facilities, especially when an additional biopsy is necessary. In 2014
17,7 per 1000 women screened received a false positive result, in almost one
third of these women (32.2%) invasive assessment was necessary. The highest
percentage of non-malignant biopsies has been observed among the participants
referred with a BI-RADS 0 result, the latter group representing 60% of all
referrals. Therefore, the need for improvement of the supplemental imaging
strategy, leading to the smallest number of biopsy referrals without missing
any cancers, is most urgent among screening participants with a BI-RADS 0 test
result.
Three-dimensional ultrasound (3DUS), a new imaging technique that enables the
acquisition of volumetric images of the whole breast, is likely to play a major
role in this improvement. Several studies have been performed on the diagnostic
accuracy of 3DUS, showing promising results. However, the lesion detection,
reliability and interobserver variability needs to be confirmed before this
technique is implemented in the imaging strategy for BI-RADS 0 referrals.
Therefore, the proposed study aims to investigate the diagnostic value of 3DUS
in Dutch screening participants referred with a BI-RADS 0 mammography result.
Study objective
To investigate the diagnostic value of 3DUS as a standalone imaging modality as
well as in combination with conventional imaging modalities to diagnose breast
cancer in Dutch breast cancer screening participants with a BI-RADS 0
mammography result.
Study design
Multicenter diagnostic study.
Study burden and risks
Participation in this study will mean that a patient undergoes a bilateral 3DUS
in addition to conventional imaging. The procedure is associated with minimal
burden; some patients might experience discomfort to mild pain during the
acquisition due to mild breast compression. Furthermore, 3DUS will take 15-20
minutes of time investment per patient. Participating patients might benefit
from the extra 3DUS as we hypothesize that the addition of the 3DUS to
conventional imaging will provide the highest diagnostic accuracy.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Participants of Dutch breast cancer screening with a BI-RADS 0 mammography result, who are referred to one of the participating hospitals for further diagnostic work-up.
Exclusion criteria
Inability to understand study information
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL61243.041.17 |
| OMON | NL-OMON29659 |