Accuracy of Fuji Amulet DBT views versus standard mammographic views

  • Research type

    Research Study

  • Full title

    Accuracy of Fuji Amulet DBT views versus standard mammographic views for the diagnosis of soft tissue breast lesions (excluding microcalcification)

  • IRAS ID

    209275

  • Contact name

    Rabea Haq

  • Contact email

    rabea.haq@elht.nhs.uk

  • Sponsor organisation

    East Lancashire Hospitals NHS Trust

  • Duration of Study in the UK

    1 years, 0 months, 0 days

  • Research summary

    Breast tomosynthesis study comparing standard mammography and tomosynthesis using the Fuji tomosynthesis machine in breast screening patients

    Tomosynthesis is an x-ray of the breasts that provides 3D images. Initial studies show that tomosynthesis should offer increased accuracy compared with standard mammography. Before new techniques can be used, it is important to consider whether it will improve what we are already doing.

    Mammography is our standard method for detection of breast cancer, although in some cases we are unable to distinguish between harmless benign conditions and breast cancer. This means ladies have needle biopsies and are ultimately shown not to have breast cancer. This is a negative aspect of mammography screening which needs to be improved.

    The current available information about tomosynthesis suggests that it may be useful in reducing the number of unnecessary needle biopsies by providing us with more detailed views of the breast tissue from which a more definite diagnosis can be made.

    We are investigating whether in the future it will be possible to replace some of our standard mammograms with Fuji tomosynthesis.

    Women participating in the breast screening programme (aged 47 and over) with specific changes on screening mammograms which could represent breast cancer will be invited to participate in the study. The study will be completed at East Lancashire Breast Screening Unit based at Burnley General Hospital.

    The participants will have standard mammograms and tomosynthesis and the images will be compared to see if tomosynthesis is as good as or better than standard mammography and to see if the number of needle biopsies are reduced.

    The expected duration of the study is 12 months. The sponsor is East Lancashire Hospitals NHS Trust and NHS Breast Screening Programme will partly be funding the study.

  • REC name

    Yorkshire & The Humber - South Yorkshire Research Ethics Committee

  • REC reference

    17/YH/0214

  • Date of REC Opinion

    21 Jul 2017

  • REC opinion

    Further Information Favourable Opinion