Use of Non-invasive Electrical Impedance Mammography in the Detection, Diagnosis and Characterisation of Breast Lesions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Primary Objective
- To test the accuracy of identification of breast malignancy, localisation and tissue characterisation, utilising the non-invasive / non-ionising imaging technique of Electrical Impedance Mammography Secondary Objectives
- Comparative analysis to other imaging modalities for detecting malignant breast disease. Since the Signascan EIM images will be being undertaken in parallel to other imaging modalities it will be possible to perform comparative analyses.
- Determination of whether Electrical Impedance Mammography (EIM) can also be used to identify and tissue-characterise the range of benign clinical breast masses.
Summary of Study Design A pilot study of a system for impedance-based breast screening, designed as a prospective diagnostic pilot study. The procedures for the study will be 'additive', and run in parallel to existing NHS care, therefore no normal investigation or treatment will be withheld. All participant involvement will be during one visit to the hospital, which will be a visit the patient would be making anyway in the course of their routine NHS care pathway. Participation will last only for the time taken to discuss, consent (15 min) and perform (10 min) the scan. Therefore total duration of involvement will be approximately 25 minutes. The pilot study will run for a period of two years, and will aim to include 300 cases of malignant breast disease. Interim analysis will be performed on the first 100 patients. Concepts of blinding/randomization do not apply as they would in a therapeutic trial. Control data will come both from patients' (when normal) contralateral breasts, and from the group of patients scanned but subsequently diagnosed as having benign disease.
5.2 Primary and Secondary Endpoints/Outcome Measures
Primary Outcome Measure:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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