TOMMY Trial (a comparison of tomosynthesis with digital mammography in the UK NHS breast screening programme) setting up a multicentre imaging trial

Introduction

Digital breast tomosynthesis (DBT) has the potential to improve the accuracy of standard digital mammography (DM) [1]. The TOMMY Trial is a multicentre, multireader, retrospective matched comparison of the diagnostic performance of DBT and DM.

Methods

Study population

Women (47 to 73 years old) recalled for further assessment after routine breast screening and women <50 years with a family history of breast cancer, attending annual mammographic screening. Intervention Women who consent to participate in the trial undergo standard two-view DM and DBT imaging of both breasts. Images are acquired in a single examination under the same degree of breast compression on a commercially available (Hologic) digital mammography system.

Outcome measures

The primary outcome measure is the relative sensitivity and specificity of DM and DBT in the detection of early-stage cancers and subtle lesions, particularly in women with dense breasts. This will be evaluated in a retrospective reading study where readers at each centre conduct blinded independent reviews of anonymised DM, or DBT, or DM and DBT images of cases from other centres.

Results

The trial set-up has involved lengthy and complex legal negotiation with collaborating sites, the equipment manufacturer and the grant-awarding body. Designated readers from each centre have completed tomosynthesis training and recruitment has commenced.

Conclusion

It should be noted that the negotiation of contracts and commercial agreements adds a considerable time burden to the set-up phase of multicentre trials.