Condition category
Cancer
Date applied
31/01/2018
Date assigned
12/02/2018
Last edited
12/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

N/A

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

http://www.ahspartnership.org.uk/tasc

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

Publication citations

Additional files

Editorial Notes