Performance Evaluation of the MARIA (Multi Static Array Processing of Radiowave Image Acquisition) Radar Breast Imaging System in Patients With Breast Cancer and in Patients Assessed in the Symptomatic Breast Clinic.
试验速览
- 阶段
- 不适用
- 入组人数
- 994
- 主要终点
- Proportion of patients with breast cancer in whom breast cancer is correctly identified by MARIA
研究概览
简要总结
The MARIA breast imaging system is a novel CE-marked radio-frequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. The performance and imaging characteristics of MARIA are not yet well demonstrated. The investigators aim to evaluate some aspects of this potentially important new technology.
详细描述
The early diagnosis of breast cancer is of paramount importance, with a 5-year survival rate of 97% if the cancer is caught "locally", deteriorating to 79% if it has progressed to the "axillary" lymph nodes, and 23% if it has spread to the rest of the body, known as "metastasised."
Diagnosis is currently achieved through clinical examination, imaging with mammography (MMG) and/or ultrasound (US) and needle biopsy. Mammography is dependent upon adequate breast compression to allow greater contrast differentiation between tissue structures, this is not only uncomfortable, but in younger women with 'dense' breast tissue the contrast difference between normal tissue and tumour is minimal despite compression. Furthermore mammography uses ionising radiation, which means that a risk/benefit calculation is weighted against repeated or frequent use. Frequently it is necessary to use additional imaging such as ultrasound or MRI for diagnostic support.
Breast tumours have an additional property that can distinguish them from normal and this is defined by the dielectric value. This has two components - the dielectric constant, which affects the velocity of propagation of radio waves and therefore their wavelength, and the conductivity, which affects the rate of attenuation. Typically a tumour has a dielectric constant of 45-50 and a conductivity of 2S/m, whereas breast fat is 5-15 and 0.2-1S/m respectively but with considerable range. Normal glandular tissue is intermediate. These differences in dielectric constant enable a consideration of the value of this data in breast cancer diagnosis.
Several attempts to exploit this property for imaging have been made. The outcomes have been similar in that the presence of a tumour is detectable, however limitations in depth for detection and mode of the technology were identified.
Due to updated technology in the MARIA device, previous limitations from similar studies are not reported to be a problem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Attending a symptomatic breast care clinic OR Patients who have a diagnosed or suspected breast cancer (P5/M5/U5/B5).
- •Female sex
- •18 years or older.
- •Able to provide informed consent.
- •Not in any identified, vulnerable group.
排除标准
- •Unable to mount MARIA™ patient bed using provided 2-step
- •Unable to lie in the prone position
- •Patients who have undergone biopsy less than 5 days before the MARIA™ scan
- •Patients with implanted electronics.
- •Patients with breast implants.
- •Patients with nipple piercings (unless they are removed prior to the MARIA™ scan)
- •Breast sizes smaller than 197ml or greater than 1L in volume
研究组 & 干预措施
Breast cancer accuracy
Patients with a known or suspected (and subsequently proven) breast cancer
干预措施: MARIA scan (Diagnostic Test)
Imaging characteristics and performance
Patients attending the symptomatic clinic
干预措施: MARIA scan (Diagnostic Test)
Tumour response in neoadjuvant treatment
Patients who are being treated with neoadjuvant chemotherapy or endocrine treatment
干预措施: MARIA scan (Diagnostic Test)
结局指标
主要结局
Proportion of patients with breast cancer in whom breast cancer is correctly identified by MARIA
时间窗: 1 week (after histopathology result)
Comparison to histopathology result
Sensitivity and specificity of MARIA for a range of findings to include, simple cysts, fibroadenomata, and malignant lesions. As judged against the final diagnosis at discharge, which may be based on clinical findings, imaging and pathology data.
时间窗: Through study completion, an average of 1 year
Comparison with clinical, radiology and pathology findings
Proportion of post-operative patients treated with neo-adjuvant chemotherapy or endocrine therapy, correctly identified by MARIA with complete response or residual disease, as compared to surgical histology.
时间窗: Through study completion, an average of 1 year
Comparison of response to surgical histology
次要结局
- Compare the detection of breast cancer from MARIA with the detection from mammography by the sub-group of histology type.(Through study completion, an average of 1 year)
- Compare the detection of breast cancer from MARIA with the detection from mammography by sub-group of mammographic density.(Through study completion, an average of 1 year)
- Compare the detection of breast cancer from MARIA with the detection from mammography in the overall patient group.(Through study completion, an average of 1 year)
- Assessment of data repeatability (test re-test) of MARIA assessment results on patients with diagnostic follow-up imaging.(After attendance for further imaging, at 1-2 weeks.)
- Investigate the performance of MARIA in the estimation of residual tumour size compared to the final surgical histology results in the case of patients receiving neo-adjuvant chemotherapy or endocrine therapy.(Through study completion, an average of 1 year)
- Patient tolerance of MARIA (a non-compressing, non-ionising modality)(Through study completion, an average of 1 year)