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

NCT01217489 | Terminated DMC

• 2 other identifiers: 09/H0308/1207/09/08 V1.3
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

breast; cancer; diagnosis; electrical; non-invasive; mammography

Study Arms (1)

Attendees to symptomatic breast clinic

Procedure: Breast scan - Electrical Impedance Mammography

Interventions

Breast scan - Electrical Impedance Mammography PROCEDURE

Scanning of the breast on a non-invasive device, using harmless minute electrical currents

Also known as: Signascan EIM

Attendees to symptomatic breast clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford Radcliffe Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jane Clarke, Mb BCh

  Oxford Radcliffe Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: October 8, 2010
• Study Start: August 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: September 21, 2012
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

GB (1)