CONTEST Study - Accuracy of contrast enhanced breast tomosynthesis: A comparison with digital mammography and breast MRI
| ISRCTN | ISRCTN12691785 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12691785 |
| IRAS number | 237233 |
| Secondary identifying numbers | 2017ON01, IRAS 237233 |
- Submission date
- 31/01/2018
- Registration date
- 12/02/2018
- Last edited
- 08/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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 July 2023
Who is funding the study?
Chief Scientist Office (Scotland)
Who is the main contact?
1. Patsy Whelehan (Scientific/Public)
patsy.whelehan@nhs.scot
2. Dr Kulsam Ali (Public)
k.z.ali@dundee.ac.uk / 01382 383967
Contact information
Public
School of Medicine
Ninewells Hospital and Medical School
University of Dundee
Dundee
DD1 9SY
United Kingdom
| Phone | +44(0)1382 383967 |
|---|---|
| k.z.ali@dundee.ac.uk |
Scientific
School of Medicine
Ninewells Hospital and Medical School
University of Dundee
Dundee
DD1 9SY
United Kingdom
| Phone | +44(0)1382 632813 |
|---|---|
| patsy.whelehan@nhs.scot |
Study information
| Study design | Prospective single-centre paired comparison study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | CONTEST study: CONTrast Enhanced breaSt Tomosynthesis (CONTEST) in patients suspected of having breast cancer: a prospective comparison with digital mammography and breast MRI |
| Study acronym | CONTEST |
| Study objectives | 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(s) | North of Scotland Research Ethics Service (REC2), 09/01/2018, ref: 17/NS/0123 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 28/06/2017 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 87 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2018 |
| Date of final enrolment | 31/05/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centre
Dundee
DD1 9SY
United Kingdom
Sponsor information
University/education
Tayside Medical Science Centre
Ninewells Hospital & Medical School
Research & Development Office
Residency Block, Level 3
George Pirie Way
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | +44 (0)1382 383900 |
|---|---|
| TASCgovernance@dundee.ac.uk | |
| Website | http://www.ahspartnership.org.uk/tasc |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.0 | 31/05/2021 | 05/09/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
08/11/2024: The intention to publish date was changed from 31/10/2024 to 31/01/2025.
09/07/2024: The intention to publish date was changed from 31/07/2024 to 31/10/2024.
09/04/2024: The intention to publish date was changed from 30/04/2024 to 31/07/2024.
17/01/2024: The following changes were made to the study record:
1. The overall end date was changed from 31/07/2023 to 31/12/2023.
2. The intention to publish date was changed from 31/01/2024 to 30/04/2024.
05/06/2023: The following changes were made to the study record:
1. Total final enrolment and IRAS number added.
2. The recruitment end date was changed from 30/04/2023 to 31/05/2023.
3. The intention to publish date was changed from 31/12/2022 to 31/01/2024.
05/09/2022: Uploaded protocol (not peer-reviewed) as an additional file.
23/08/2022: The following changes were made to the trial record:
1. The overall end date was changed from 28/02/2022 to 31/07/2023.
2. The recruitment end date was changed from 28/02/2022 to 30/04/2023.
3. The plain English summary was updated to reflect these changes.
27/01/2022: The recruitment end date has been changed from 31/01/2022 to 28/02/2022.
14/12/2021: The recruitment end date has been changed from 31/12/2021 to 31/01/2022.
26/10/2021: The following changes were made to the trial record:
1. The scientific contact was changed.
2. The recruitment end date was changed from 01/11/2021 to 31/12/2021
3. The overall end date was changed from 31/12/2021 to 28/02/2022.
4. The sponsor email was updated.
5. England and Wales were added to the countries of recruitment.
6. The plain English summary was updated to reflect these changes.
06/04/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2021 to 01/11/2021.
2. The overall end date was changed from 31/05/2021 to 31/12/2021.
3. The intention to publish date was changed from 31/07/2021 to 31/12/2022.
4. The plain English summary was updated to reflect these changes.
20/10/2020: Recruitment to this study is no longer paused. The recruitment end date was changed from 31/08/2020 to 30/04/2021.
04/09/2020: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2020 to 31/05/2021.
2. The intention to publish date was changed from 31/12/2021 to 31/07/2021.
3. The plain English summary was updated to reflect these changes.
11/05/2020: The recruitment end date has been changed from 30/04/2020 to 31/08/2020.
24/04/2020: Due to current public health guidance, recruitment for this study has been paused.
04/06/2018: The following changes have been made:
1. The scientific title has been changed back to "CONTEST study: CONTrast Enhanced breaSt Tomosynthesis (CONTEST) in patients suspected of having breast cancer: a prospective comparison with digital mammography and breast MRI".
2. The public title has been changed from "CONTEST study - accuracy of breast tomosynthesis (3-dimensional breast scanning) in patients suspected of having breast cancer: comparison with mammogram and breast MRI scanning" to "CONTEST Study - Accuracy of contrast enhanced breast tomosynthesis: A comparison with digital mammography and breast MRI."
31/05/2018: The following changes have been made:
1. The scientific title has been changed from "CONTrast Enhanced breaSt Tomosynthesis (CONTEST) in patients suspected of having breast cancer: a prospective comparison with digital mammography and breast MRI" to "CONTEST Study - Accuracy of contrast enhanced breast tomosynthesis: A comparison with digital mammography and breast MRI".
2. The scientific contact has been updated.
3. The recruitment start date has been changed from 01/03/2018 to 01/05/2018.
4. The recruitment end date has been changed from 29/02/2020 to 30/04/2020.
5. The plain English summary has been changed to reflect the change in contact person.
