Contrast Enhanced Spectral Mammography Study
Research type
Research Study
Full title
An assessment of the impact of Contrast Enhanced Spectral Mammography (CESM) on patient management and comparison with MRI (CONTEND Study)
IRAS ID
174346
Contact name
Fiona J Gilbert
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Trust and University of Cambridge
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 3 days
Research summary
The aim of this study is to determine if the addition of Contrast Enhanced Spectral Mammography (CESM) to standard diagnostic imaging, results in a decision regarding patient management - discharge, follow-up, surgery or treatment - being made sooner than it would if the patient had followed the standard course of investigations and review.
Patients who are found to have an area of suspicion on their mammogram and /or ultrasound examination will be asked to participate in the study. Written, informed consent will be taken and the patient randomised to receive either CESM in addition to standard care or standard care alone. Those randomised to undergo CESM will have the procedure either on the same day or another day. Patients will receive an intra-venous injection of a contrast media (dye) routinely used in CT procedures. A series of X-ray images will then be taken with patient positioned as for a standard mammogram. A high energy and low energy exposure is made is each of four positions producing a total of eight images. Images will be examined for enhancement of suspicious area and any additional areas. Following CESM patients will return to standard care.
We also intend to compare CESM with MRI. Images and pathology results from patients who undergo both CESM and MRI will be reviewed retrospectively for detection of abnormality and identification of type of abnormality.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0279
Date of REC Opinion
24 Oct 2015
REC opinion
Further Information Favourable Opinion