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 designNon-randomised; Interventional; Design type: Diagnosis
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA non-randomised interventional study comparing TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme
Study acronymTOMMY trial
Study objectivesThe 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) studiedTopic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measuresVisibility of multifocal lesions and microcalcification detection
Overall study start date01/02/2011
Completion date29/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsPlanned Sample Size: 7000; UK Sample Size: 7000
Total final enrolment8869
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2011
Date of final enrolment29/06/2012

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.