TOMMY trial: A comparison of TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme

ISRCTN	ISRCTN73467396
DOI	https://doi.org/10.1186/ISRCTN73467396
Secondary identifying numbers	9464

Submission date: 06/05/2011
Registration date: 06/05/2011
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-standard-mammograms-with-new-type-digital-mammogram-screen-for-breast-cancer-tommy-trial

Contact information

Dr Maureen Gillan
Scientific

Aberdeen Biomedical Imaging Centre
Lilian Sutton Building
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Email	m.g.gillan@abdn.ac.uk

Study information

Study design	Non-randomised; Interventional; Design type: Diagnosis
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A non-randomised interventional study comparing TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme
Study acronym	TOMMY trial
Study objectives	The trial will compare the accuracy of digital breast tomosynthesis (DBT) with standard digital full field mammography (FFDM) in the diagnosis of breast cancer. A limitation of standard mammography is that overlapping dense fibroglandular tissue in normal breast tissue can decrease the visibility of malignant abnormalities, or mimic abnormalities. DBT is a newly developed three dimensional (3D) imaging technique that has the potential to improve the accuracy of mammography by reducing interference from tissue overlap and facilitating differentiation between malignant and non malignant features. The aim of the trial is to assess whether DBT could improve upon digital mammography as a screening tool, particularly in certain groups of women e.g. those with a family history of breast cancer, or women with dense breasts. The diagnostic accuracy of DBT, FFDM and DBT+FFDM will be evaluated in an independent retrospective reading study in and compared to the final clinical outcome for each case.
Ethics approval(s)	Scotland A Research Ethics Committee; First MREC approval date 27/05/2010, 10/MRE00/39
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Intervention	Participants will be recruited over a 15-18 month period from six UK Breast Screening Centres. This should provide sufficient cancer cases to compare the sensitivity and specificity of the three imaging modalities. Participants in the trial will have a standard two-view (MLO and CC) digital mammography examination of each breast and a two-view (MLO and CC) digital breast tomosynthesis examination of each breast. The digital mammogram and tomosythesis imaging will be acquired during the same breast compression
Intervention type	Other
Primary outcome measure	1. Cancer detection rate (early stage cancers (<15mm)/subtle lesions/cancers in women with dense breasts); Timepoint(s): At end of retrospective reading study 2. Recall rate; Timepoint(s): At end of retrospective reading study
Secondary outcome measures	Visibility of multifocal lesions and microcalcification detection
Overall study start date	01/02/2011
Completion date	29/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 7000; UK Sample Size: 7000
Total final enrolment	8869
Key inclusion criteria	1. Women (aged 47-73) recalled to an assessment clinic following abnormal screening mammography 2. Women (aged 40-49) with a family history of breast cancer attending annual screening mammography; Target Gender: Female; Upper Age Limit 73 years ; Lower Age Limit 40 years
Key exclusion criteria	1. Women unable to give informed consent, including anyone unable to understand the nature and purpose of the study 2. Women with breast implants 3. Women who are pregnant
Date of first enrolment	01/02/2011
Date of final enrolment	29/06/2012

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Aberdeen Biomedical Imaging Centre

Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

University of Aberdeen (UK)
University/education

Kings College
University of Aberdeen
Aberdeen
AB24 3FX
Scotland
United Kingdom

"ROR"	https://ror.org/016476m91

Funders

Funder type

Government

National Institute of Health Research (NIHR)-HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2015		Yes	No
Results article	results	01/05/2015		Yes	No
Plain English results			26/10/2022	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.