Pilot Clinical Evaluation of a Microwave Imaging System for Early Breast Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Serious Adverse Events, Directly Related to Normal Functioning of the Device
研究概览
简要总结
The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.
Microwave imaging is an emerging imaging modality for the early detection of the breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at microwave frequencies. Microwave imaging can potentially be used for monitoring neoadjuvant chemotherapy treatment, breast health monitoring, and for routine screening and diagnosis of the breast cancer at the early-stage. The non-invasive and the non-ionizing characteristics of microwaves should allow for frequent scans of the breast using microwave imaging, unlike X-ray mammography. In addition to safety, microwave imaging does not require uncomfortable breast compression and it is potentially a lower-cost modality.
This is a first-in-human clinical test of the investigational device, which has been so far tested only with experimental phantoms modelling the human female breast.
The clinical data that will be collected in the context of this study is intended to provide early safety information for the investigational medical imaging device. In addition, this exploratory data will guide the refinement of the device hardware and the imaging algorithm design, before decision to proceed (or not) with further clinical tests.
Furthermore, this study will be used to guide sample size calculation for a subsequent study designed to evaluate efficacy should that appear warranted once this study is completed.
详细描述
This is a single-site early-phase pilot clinical study, taking place at Galway University Hospital/HRB Clinical Research Facility, Galway.
Patients will have a conventional history and breast examinations (Mammogram and / or Ultrasound and Clinical assessment) performed by the physician, as per normal practice in the Symptomatic Breast Unit of University Hospital Galway.
If patients are interested in the study, provide written informed consent and are deemed eligible, they will attend the Clinical Research Facility Galway for a Microwave Breast Imaging (MBI) scan. The data from the scan will be collected and stored securely. Patients will be followed up 7-21 days after the microwave breast investigation or before surgery, whichever comes first. Patients will be assessed for their experience of the microwave breast investigation, and for any adverse events.
The investigational medical imaging device consists of two subsystems, both performing a non-invasive examination:
- the Microwave Breast Imaging subsystem (MBI subsystem);
- the Optical Breast Contour Detection subsystem (OBCD subsystem);
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
- •Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
- •Subject must have attended the Symptomatic Breast Unit with a palpable breast lump
- •Subjects must have had a mammogram in the clinical assessment period (≤ 6 weeks before the microwave breast investigation)
- •Subjects must be able to comfortably lie reasonably still in a prone position for up to 15 minutes
- •Subjects with bra size larger than 32B and cup size larger or equal to B.
- •Subjects whose breast size is adapted to the cylindrical container of the MBI system with sufficient margin to allow the presence of transition liquid around the breast. Final decision to be taken by the physicians based on their judgement.
排除标准
- •Subjects unable to provide written informed consent
- •Subjects who are pregnant or breast-feeding
- •Subjects who have had previous surgery to the breast
- •Subjects who have previously received chemotherapy or radiotherapy to the breast
- •Subjects who have had a breast biopsy less than two weeks prior to imaging
- •Subjects with any active or metallic implant (e.g. cardiac pacemaker, stents, internal cardiac defibrillator, cardiac resynchronisation device, nerve stimulator...), or subjects bearing any non-removable metallic object (e.g. piercing) on their torso
- •Post-biopsy patients whose breast tissue is not healed sufficiently for the imaging procedure, in the opinion of the investigator
- •Patients who have had or plan to have a breast cyst aspiration before MBI.
- •Subjects with significant co-morbidities which, in the opinion of the investigator, may influence the result of the study
- •Subjects with prior or concurrent malignancy
- •Subjects under the age of 18 years old
- •Subjects with evidence of inflammation and/or erythema of the breast as well as any subjects who have a break in the skin which would be in contact with the coupling fluid
- •Subjects who would be unsuitable for an MBI scan, unlikely to attend a follow up visit, or would otherwise be unsuitable for such an investigation, in the opinion of the Investigator
结局指标
主要结局
Number of Serious Adverse Events, Directly Related to Normal Functioning of the Device
时间窗: Through study completion, up to 21 days
To provide early safety information for the proposed investigational medical imaging device.
次要结局
未报告次要终点