Plain English Summary
Background and study aims
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 x-ray 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.
The aim of the study is to find out whether CE-DBT is better than a standard mammogram, and is as good as breast magnetic resonance imaging (MRI) to show tumour size.
Who can participate?
Women between the ages of 18-70 years old who have a high suspicion of breast cancer that can be operated on.
What does the study involve?
Participants receive a standard mammogram, and the new procedure CE-DBT. For this, participants have a special dye called contrast medium injected into the veins before the x-ray is taken. Some participants also have an MRI scan and all receive an ultrasound scan. If there are any areas of concern in the breast the participants may have a sample of cells taken by a needle biopsy.
Everybody completes a short questionnaire after the CE-DBT procedure and MRI scan to provide information about how they felt during each procedure.
What are the possible benefits and risks of participating?
Although it is not known, CE-DBT may provide better information than the standard tests potentially resulting in receiving the right diagnosis more quickly. There is also a chance that it will be easier to work out the most suitable treatment for a patient and increase certainty that no areas of concern have been missed if a participant’s results show no serious breast problem.
The injection needed for this test is generally very safe. However, with every injection of the dye, there is a very slight risk of a reaction. Some participants may develop a rash, and a few people may get a mild asthma attack. More serious reactions are very unusual.
The dye used for the test can affect the kidneys (less than 1 in 100 people). The test will not be offered if there are any risk factors or known kidney problems.
All x-rays involve radiation. The amount of radiation from a standard mammogram is small. It is similar to the amount of radiation received naturally from the environment over a period of a few months. The radiation dose from CE-DBT is higher than that of a standard mammogram, but still well within accepted safety guidelines.
Where is the study run from?
Ninewells Hospital Dundee (UK)
When is the study starting and how long is it expected to run for?
June 2017 to September 2020
Who is funding the study?
Chief Scientist Office (Scotland)
Who is the main contact?
1. Dr Sarah Vinnicombe (Scientific)
sarah.vinnicombe@nhs.net / 01382 383286
2. Dr Kulsam Ali (Public)
k.ali@dundee.ac.uk / 01382 383967
3. Professor Andy Evans (Public)
a.z.evans@dundee.ac.uk / 01382 383014
Trial website
Contact information
Type
Public
Primary contact
Dr Kulsam Ali
ORCID ID
Contact details
School of Medicine
Ninewells Hospital and Medical School
University of Dundee
Dundee
DD1 9SY
United Kingdom
+44(0)1382 383967
k.z.ali@dundee.ac.uk
Type
Scientific
Additional contact
Dr Sarah Vinnicombe
ORCID ID
http://orcid.org/0000-0003-4956-1266
Contact details
School of Medicine
Ninewells Hospital and Medical School
University of Dundee
Dundee
DD1 9SY
United Kingdom
+44(0)1382 383286
s.vinnicombe@dundee.ac.uk
Additional identifiers
EudraCT number
N/A
ClinicalTrials.gov number
N/A
Protocol/serial number
2017ON01
Study information
Scientific title
CONTrast Enhanced breaSt Tomosynthesis (CONTEST) in patients suspected of having breast cancer: a prospective comparison with digital mammography and breast MRI
Acronym
CONTEST
Study hypothesis
The aim of this study is to evaluate the performance of contrast-enhanced digital breast tomosynthesis (CE-DBT) in the identification and local staging of symptomatic breast cancer. We hypothesise that the diagnostic performance of CE-DBT will be significantly better than that of digital mammography (DM) and that it will not significantly differ from breast MRI in local staging and evaluation of local extent of breast cancer. The primary objective is to determine the incremental increase in sensitivity of CE-DBT over DM alone in women with symptoms/signs suspicious for breast cancer, the latter currently being standard of care.
Ethics approval
North of Scotland Research Ethics Service (REC2), 09/01/2018, ref: 17/NS/0123
Study design
Prospective single-centre paired comparison study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Cancer
Intervention
All participants receive the equivalent of standard care, a Digital Mammogram (DM) and the experimental procedure which is the Contrast Enhanced Digital Breast Tomosythesis (CE-DBT). Needle biopsy is carried out according to standard clinical practice if there are any areas of concern. All recruits with biopsy-proven breast cancer also undergo breast MRI but in a proportion this will be a study-specific procedure, and participants complete a short questionnaire after the CE-DBT and MRI to inform how they felt during the procedures.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Sensitivity of CE-DBT compared with DM using surgical pathology as the gold standard.
Secondary outcome measures
1. Correlation of tumour size measurements with CE-DBT compared to MRI, using surgical pathology as the gold standard
2. Identification of multifocality with CE-DBT compared to MRI, using surgical pathology as the gold standard
3. Patient perspectives on the CE-DBT procedure is measured using a questionnaire after the procedure
4. Patient perspectives on the MRI scan is measured using a questionnaire after the procedure
Overall trial start date
28/06/2017
Overall trial end date
30/09/2020
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18 to 70 years inclusive
2. Female
3. Able to give informed consent
4. Clinical examination findings suspicious or typical of operable breast cancer (E4/5)
AND/OR
5. Ultrasound findings suspicious or typical of malignancy (U4/5)
6. Able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
1. History of prior iodinated contrast reaction
2. Iodine allergy
3. Severe asthma
4. Known renal impairment, strong risk factors for renal disease
5. Previous breast cancer surgery or implants
6. Current pregnancy, lactation
7. Inflammatory or clinically obvious locally advanced (inoperable) primary breast cancer who are likely to receive neoadjuvant chemotherapy (in these patients, imaging/pathological correlation will not be possible)
8. Contraindication to MRI
9. Obvious severe comorbidities precluding operative treatment
10. Otherwise deemed to be unsuitable by the clinical team
Recruitment start date
01/03/2018
Recruitment end date
29/02/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ninewells Hospital
Ninewells Avenue
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee and NHS Tayside
Sponsor details
Tayside Medical Science Centre
Ninewells Hospital & Medical School
Research & Development Office
Residency Block
Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383900
tasctayside@nhs.net
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (Scotland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal in 2021.
IPD sharing statement:
The data is held by the sponsor. After 5 years of publication, data can be requested from the chief investigator or sponsor. Sharing of data will be subject to a Material Transfer Agreement being in place.
Intention to publish date
31/12/2021
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary