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Study Into the Use of Electrical Impedance Mammography in the Diagnosis and Characterisation of Breast Disease (Signascan)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Zoe Crookes, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01217489
First received: August 18, 2009
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Procedure: Breast scan - Electrical Impedance Mammography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Non-invasive Electrical Impedance Mammography in the Detection, Diagnosis and Characterisation of Breast Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oxford University Hospitals NHS Trust:

Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Attendees to symptomatic breast clinic Procedure: Breast scan - Electrical Impedance Mammography
Scanning of the breast on a non-invasive device, using harmless minute electrical currents
Other Name: Signascan EIM

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants to be included will be women referred for NHS investigation of symptomatic breast lump, following self-examination or picked up by GP. They will generally be in the age range 40-60 years but no eligible patients over 18 yrs will be excluded from the study on the basis of age.

Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study
  • Female, aged 18 years or above
  • Attending for investigation of symptomatic breast lump

Exclusion Criteria:

  • Pacemaker or critical implanted electronic device
  • Under the age of 18 years
  • Adults with learning disabilities
  • Adults who are unconscious or very severely ill
  • Adults who have a terminal illness
  • Adults in emergency situations
  • Adults suffering from a mental illness
  • Adults with dementia
  • Prisoners
  • Young offenders
  • Adults who are unable to consent for themselves
  • Any person considered to have a particularly dependent relationship with investigators
  • Any others deemed to belong to a vulnerable group
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217489

Locations
United Kingdom
Oxford Radcliffe Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
Zoe Crookes
Investigators
Principal Investigator: Jane Clarke, Mb BCh Oxford Radcliffe Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Zoe Crookes, On behalf of WZVI Ltd., Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01217489     History of Changes
Other Study ID Numbers: 09/H0308/12, 07/09/08 V1.3
Study First Received: August 18, 2009
Last Updated: February 5, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Oxford University Hospitals NHS Trust:
breast
cancer
diagnosis
 electrical
non-invasive
mammography

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013