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

A non-randomised interventional study comparing TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73467396
Enrollment
7000
Registered
2011-05-06
Start date
2011-02-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: National Cancer Research Network

Interventions

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 imag

Sponsors

University of Aberdeen (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Visibility of multifocal lesions and microcalcification detection

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026