TOMMY trial:Comparison of TOMosynthesis with digital MammographY
Research type
Research Study
Full title
TOMMY trial: A comparison of TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme.
IRAS ID
45125
Contact name
Fiona J Gilbert
Sponsor organisation
Norfolk and Norwich NHS Foundation Trust
Eudract number
N/A
Research summary
This study will compare the accuracy of digital breast tomosynthesis with standard digital x-ray mammography in the diagnosis of breast cancer. One of the limitations of standard mammography is that overlapping breast tissue can make it difficult to see some cancers or mimic the appearance of a cancer. Women who are recalled for a suspected abnormality following their mammographic screening examination will be invited to take part in the trial to have a further digital mammogram and tomosynthesis examination. In addition, younger women (40-47years) who have a family history of breast cancer and are attending annual breast screening will also be eligible for the study. 7,000 cases will be collected and then re-read blindly. The two sets of images will be scored independently by breast specialists using a 1-5 scale (1=normal, 2=benign, 3= probably benign, 4=suspicious, 5=malignant). The accuracy of mammography and tomosynthesis scoring will be compared to the final outcome (normal/benign/malignant) of each case after completion of all tests. A comparison of standard mammography and tomosynthesis will indicate if tomosynthesis would be better for detecting breast cancer and whether it could be more effective in women with dense breasts. The study will also determine if tomosynthesis reduces the number of false positive recalls that cause unnecessary anxiety and additional healthcare costs. This will give an indication as to whether this technology should be used for screening and in which groups of women.
REC name
Scotland A REC
REC reference
10/MRE00/39
Date of REC Opinion
31 May 2010
REC opinion
Favourable Opinion