GE tomosynthesis versus supplementary mammographic views
Research type
Research Study
Full title
Accuracy of GE digital breast tomosynthesis versus supplementary mammographic views for diagnosis of screen-detected soft-tissue breast lesions
IRAS ID
133527
Contact name
Eleanor J Cornford
Contact email
Sponsor organisation
Research and Innovation, NUH NHS Trust
Research summary
Tomosynthesis is an advanced form of digital mammography, providing 3D-like images of the breast tissue. Early clinical research is tending to support the theory that tomosynthesis should offer increased accuracy compared with standard mammography.
Mammography is our current primary method for detection of breast cancer, however it has significant limitations. One limitation is that in some cases we are unable to distinguish benign conditions from cancer and will therefore subject ladies (who are ultimately shown not to have cancer at all) to further tests, including in some cases biopsy. This is a negative aspect of mammography screening which needs to be improved upon.
This study aims to assess whether digital breast tomosynthesis can improve upon our current standard of care for assessment of soft tissue abnormalities picked up on screening mammograms.
The study will involve ladies who have been recalled following an abnormal mammogram as part of the NHS Breast Screening Programme.
The study involves two sites, the Breast Units at Nottingham University Hospital and Derby General Hospital.
It is anticipated that the study will last approximately 9 months.
At the assessment clinic an individual patient will receive the usual standard of care for the abnormality detected on her initial mammogram. This will usually involve spot compression views (special mammographic views of the abnormal area) and ultrasound. If these suggest the abnormality is real the patient will undergo a breast biopsy. In addition the patient will also undergo breast tomosynthesis.
A retrospective analysis will take place of the spot compression views and tomosynthesis to assess accuracy.
It is anticipated that the participants will require one clinic attendance as part of the trial. However an audit mechanism is built into the trial such that if on review an abnormality is detected which was not picked up in clinic she will be asked to reattend.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0457
Date of REC Opinion
17 Dec 2013
REC opinion
Favourable Opinion