CIST full study
Research type
Research Study
Full title
Spectral mammography for lesion characterization: (Characterization using Imaging with Spectral mammography of Tissue – CIST study)
IRAS ID
163959
Contact name
Matthew Wallis
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
Mammography is the main stay of screening for and diagnosing breast cancer with over 2 million women being screened in the UK every year. It is far from perfect with 90,000 women being recalled from screening unnecessarily, some of these will never return for screening. 10% of recalls are due to cysts.
Philips L50 MicroDose Mammography equipment uses a detector that counts individual photons. It has recently been modified so that it can separate the x-rays in to 2 energy levels. In 2011/12 The Cambridge Breast Unit demonstrated that we can use this spectral information to distinguish cyst fluid from solid (cancer and innocent) breast masses in the laboratory. More recent pilot work on a commercially available CE marked model collected spectral information from women attending for their normal care.
On the basis of data from 133 mass lesions 53% of solitary cysts greater than 1 cm in size could be correctly characterised at the risk of missing one solid lesion. In Cambridge this would represent a 16% reduction in the number of women with cysts recalled from screening or a reduction in overall recall rate from 34.6 per thousand to 33.5 per thousand.
This application is to determine if these pilot results can be reproduced in a multicentre setting. Women invited to breast screening and those attending referral clinics with breast symptoms who have mammography on Philips L50 MicroDose SI equipment as part of their routine care will be asked to allow analysis of the additional spectral information. All data will be anonymised and the data obtained will not be used to alter their care.REC name
London - Queen Square Research Ethics Committee
REC reference
15/LO/0546
Date of REC Opinion
16 Mar 2015
REC opinion
Favourable Opinion