TOMMY trial: A comparison of TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme
Phase 3
Completed
- Conditions
- Topic: National Cancer Research NetworkSubtopic: Breast CancerDisease: BreastCancerBreast cancer
- Registration Number
- ISRCTN73467396
- Lead Sponsor
- niversity of Aberdeen (UK)
- Brief Summary
2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25599513 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25559234 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 8869
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Cancer detection rate (early stage cancers (<15mm)/subtle lesions/cancers in women with dense breasts); Timepoint(s): At end of retrospective reading study<br> 2. Recall rate; Timepoint(s): At end of retrospective reading study<br>
- Secondary Outcome Measures
Name Time Method Visibility of multifocal lesions and microcalcification detection