Study Into the Use of Electrical Impedance Mammography in the Diagnosis and Characterisation of Breast Disease
NCT01217489 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2017-10-12
Summary
The Signascan Electrical Impedance Mammography (EIM) Study is a pilot study of a non-invasive medical device - a novel approach to breast cancer detection using Electrical Impedance Mammography (passing minute electrical currents through the tissues and detecting the changes to the currents as a result of the tissues, which can differentiate between normal and malignant tissue). The trial is a prospective trial of diagnostic capability of the device, as compared with standard care (diagnosis provided by the concurrent NHS investigation - imaging, surgery etc) performed for female patients attending the symptomatic breast clinic for investigation. The aim is to assess the diagnostic efficacy in detecting 100 true malignancies, and continue to recruit until 300 patients with true malignancies have been recruited if necessary.
Conditions
Interventions
- PROCEDURE
-
Breast scan - Electrical Impedance Mammography
Scanning of the breast on a non-invasive device, using harmless minute electrical currents
Sponsors & Collaborators
-
Oxford University Hospitals NHS Trust
lead OTHER
Principal Investigators
-
Jane Clarke, Mb BCh · Oxford Radcliffe Hospitals NHS Foundation Trust
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2011-03-01
- Completion
- 2012-09-21
Countries
- United Kingdom
Study Locations
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