CONTEST- CONTrast Enhanced breaSt Tomosynthesis
Research type
Research Study
Full title
CONTrast Enhanced breaSt Tomosynthesis (CONTEST) in patients suspected of having breast cancer: a prospective comparison with digital mammography and breast MRI.
IRAS ID
237233
Contact name
Patsy Whelehan
Contact email
Sponsor organisation
University of Dundee
ISRCTN Number
ISRCTN12691785
Duration of Study in the UK
2 years, 8 months, 30 days
Research summary
Summary of Research
The most commonly used test to detect breast cancer is a mammogram, which is a low dose xray of the breast. Mammograms show most breast cancers, but when breast tissues are dense (a common normal variation, especially in younger women), they can be missed. This means that extra tests like magnetic resonance imaging (MRI) are needed to show if a cancer is present and also how big it is. This in turn can mean repeated visits to the Breast Unit and it slows down the patient journey before definitive treatment can be offered.
New forms of mammogram have been developed to tackle this problem. Digital breast tomosynthesis (DBT) “unwraps” overlapping shadows and shows distortion of the tissues caused by slower-growing cancers. Contrast enhanced spectral mammography (CESM) involves injection of a 'dye' that highlights cancerous tissues in the breast. This is the same 'dye' that is used in a CT scan and it tends to show faster-growing, more aggressive cancers.
In this study, we are combining these two tests into one (CE-DBT), to investigate how good this is at identifying all forms of breast cancer, when the patient attends the outpatient clinic. This new combined type of mammogram should be able to reliably identify all forms of breast cancer in a single test. In patients who are shown to have breast cancer, we will be comparing the performance of the CE-DBT test with breast MRI, which is the “gold standard” test. After patients have had an operation for their cancer, we will study how accurate CE-DBT is compared to the results of the analysis of the breast tissues.
If we show that CE-DBT works, we could greatly improve patient care by speeding up the diagnostic process and identifying any abnormal areas of the breast during a single clinic visit.Summary of Results
: Breast cancer is the most common type of cancer in the UK. Some women, particularly younger women, have dense breast tissue which makes it harder to spot cancers or areas of concern on a standard breast x-ray (mammogram). A new kind of mammogram called Contrast Enhanced Digital Breast Tomosynthesis (CE-DBT) may be particularly useful in these patients as it can highlight areas of concern even if the breasts are dense. CE-DBT consists of Digital Breast Tomosynthesis (DBT) and Contrast Enhanced Mammography (CEM) performed together.The aim of this UK-wide multicentre-study was to find out whether CE-DBT is better than a standard mammogram and as good as breast magnetic resonance imaging (MRI) to identify breast cancer and estimate tumour size.
Women between the ages of 18-70 years old who had a high suspicion of breast cancer that could be operated on were invited to take part in the study. Participants the new procedure CE-DBT in addition to standard care ultrasound and biopsy. Participants received a breast MRI scan on a separate hospital visit. All participants were asked to complete a short questionnaire after the CE-DBT procedure and MRI scan to provide information about how they felt during each procedure and which they preferred best.
A total of 87 participants were recruited, 5 withdrew or did not complete the study, and 2 participants were found to be ineligible after recruitment. 80 participants were included in the analysis of which 69 had breast cancer.
The results of the study showed that CEM had similar accuracy to MRI in detecting breast cancer and showing the tumour size. However, combining DBT with CEM (CE-DBT) did not improve the accuracy of detecting breast cancer.The data from the participant questionnaires showed that most participants preferred CE-DBT to the MRI scan. The concerns expressed about the MRI were mostly around feeling confined/enclosed, the noise, and long duration in an uncomfortable position.
REC name
North of Scotland Research Ethics Committee 2
REC reference
17/NS/0123
Date of REC Opinion
15 Dec 2017
REC opinion
Favourable Opinion