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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217489 on ClinicalTrials.gov