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 |
| Protocol serial number | 9464 |
| Sponsor | University of Aberdeen (UK) |
| Funder | National Institute of Health Research (NIHR)-HTA (UK) |
- 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
Contact information
Dr Maureen Gillan
Scientific
Scientific
Aberdeen Biomedical Imaging Centre
Lilian Sutton Building
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| m.g.gillan@abdn.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Diagnosis |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) |
1. Cancer detection rate (early stage cancers (<15mm)/subtle lesions/cancers in women with dense breasts); Timepoint(s): At end of retrospective reading study |
| Key secondary outcome measure(s) |
Visibility of multifocal lesions and microcalcification detection |
| Completion date | 29/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
Aberdeen Biomedical Imaging Centre
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
