PROSPECTS
Research type
Research Study
Full title
Prospective randomised trial of digital breast tomosynthesis (DBT) plus standard 2D digital mammography (2DDM) or synthetic 2D mammography (S 2D) compared to standard 2D digital mammography in breast cancer screening.
IRAS ID
199080
Contact name
Michael J Michell
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Duration of Study in the UK
6 years, 11 months, 27 days
Research summary
The accuracy of two view digital x-ray mammography (2DDM) in breast cancer screening is limited because of superimposition of normal breast structures onto a two dimensional image. Mammography signs of breast cancer may be obscured, particularly in women with dense glandular breast tissue, resulting in delay in diagnosis of cancer. Interval cancer data shows that up to 4000 women per annum (2.88 per 1000 screened) are diagnosed with breast cancer in the interval between screens. Conversely, superimposition of normal tissues may produce features on mammography which are suspicious for cancer and lead to unnecessary recall for further diagnostic tests.
Digital Breast Tomosynthesis (DBT) is an x-ray mammography technique which involves acquiring multiple low dose projection images over a limited angular range (less than 50 degrees). These projection images are reconstructed into a set of images consisting of parallel planes, typically 1mm apart throughout the breast, and provide three dimensional information to the film reader. A synthetic 2D mammogram (S 2D) has been developed using the data from the reconstructed DBT images.
Studies of DBT + 2DDM in screening have shown increased invasive cancer detection rates and lower false positive recall rates.There may be increased costs related to the technology and reading times.
The aim of this trial is to measure the impact and cost-effectiveness of DBT + 2DDM or S 2D in routine screening compared to standard 2DDM.
100 000 women will be recruited using NHS screening sites with DBT mammography equipment. At each site, through a clinic randomisation process, half the trial participants will undergo standard 2DDM (the control group) and half will undergo 2DDM + DBT (the intervention group). All cases will be double read - in the intervention group, one read will be DBT + 2DDM, and one read will be DBT + S 2D. Arbitration or consensus will be used for reader 1/2 discordance.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0054
Date of REC Opinion
9 Feb 2017
REC opinion
Further Information Favourable Opinion