Contact information
Type
Scientific
Primary contact
Dr Maureen Gillan
ORCID ID
Contact details
Aberdeen Biomedical Imaging Centre
Lilian Sutton Building
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
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m.g.gillan@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9464
Study information
Scientific title
A non-randomised interventional study comparing TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme
Acronym
TOMMY trial
Study hypothesis
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
Scotland A Research Ethics Committee; First MREC approval date 27/05/2010, 10/MRE00/39
Study design
Non-randomised; Interventional; Design type: Diagnosis
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
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 trial start date
01/02/2011
Overall trial end date
29/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 7000; UK Sample Size: 7000
Participant 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
Recruitment start date
01/02/2011
Recruitment end date
29/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Aberdeen Biomedical Imaging Centre
Aberdeen
AB25 2ZD
United Kingdom
Funders
Funder type
Government
Funder name
National Institute of Health Research (NIHR)-HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25559234
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25599513