Clinical validation of the illumina360 system
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to establish non-invasive method of treatment
研究概览
简要总结
Breast Cancer is a leading cause of death in women globally. Monitoring response to treatment is a key element in the management of breast cancer that involves several different viewpoints from surgery, radiology and medical oncology. In the neoadjuvant setting, assessing response to chemotherapy prior to surgery to include evaluation for pathologic response can provide prognostic information to help guide follow up care. Current imaging methods such as Ultrasound, X ray mammography and conventional computed tomography imaging can be used to study anatomical characteristics, but may be limited in showing functional and biological changes which start to occur early after treatment initiation.
The primary challenges in the neoadjuvant setting include the accurate assessment of early response to therapy and discovering a non- invasive means of accurately predicting pathologic complete response to therapy.
Illumina360 for breast imaging is a non-invasive, image acquisition and processing system for monitoring the breast tissue changes based on their physiology without any radiation. It comprises a high-resolution IR camera, integrated with the inbuilt temperature control and monitoring system, a multi axial rotating arm and positioning set up that are enclosed within a closed chamber and the special design on its top as the patient couch used for patient positioning. The configuration of the device enables capturing images all through 360 degrees of each breast at two different temperature conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •(1)Positive biopsy finding in one or both the breasts. (2) Age between 18 to 75 years. (3) Patients who can follow the instructions. (4)Age group – 18 years to 75 years (5)Sex.
- •Female (6)Willingness to participate in the study. (7)Patients who can understand the procedure.
排除标准
- •(1) Whose clinical condition does not support them lying prone during examination.
- •(2) Any infection in the breast that can spread by air or by contact with the patient table.
- •(3) Who have body fluid discharge in breast.
- •(4) Patients in a medical state who cannot follow explanations given by the clinician to participate in the study.
- •(5) Undergone procedure such as EMG, TENS, physical therapy, chiropractic, and any deep heat treatments 24 hours before the exam.
- •(6) Consumption of alcohol 12 hours prior to the exam.
- •(8) Bathing in last 1 hour from the exam.
- •(9) Usage of heat or cold packs on the day of the exam.
- •(10) Use of skin creams, perfume, powders or deodorants on the day of the exam.
- •(11) Smoking in last 4 hours from the exam.
结局指标
主要结局
The primary objective of this study is to establish non-invasive method of treatment
时间窗: 6 months
assessment using rotational thermography device, illumina360 and correlating the findings
时间窗: 6 months
from thermographic breast images with standard imaging modalities such as USG
时间窗: 6 months
(ultrasonography) and/or CT/ PET CT.
时间窗: 6 months
次要结局
- To characterize the breast tissue changes based on the difference in temperature pattern(derived from thermographic breast images against the clinical and imaging findings ( USG/)