Condition category
Cancer
Date applied
06/05/2011
Date assigned
06/05/2011
Last edited
20/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
-
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 measures

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

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

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

Kings College
University of Aberdeen
Aberdeen
AB24 3FX
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25559234
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25599513

Publication citations

Additional files

Editorial Notes