Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Optical sensitivity of the MRg-NIRS platform
研究概览
简要总结
This trial is a study of 20 women with breast cancer to evaluate the addition of MR-guided (MRg) near-infrared spectroscopy (NIRS) with and without contrast, as part of a program to improve clinical management of women receiving breast magnetic resonance imaging (MRI).
详细描述
This trial is designed to determine if the MRg-NIRS system will contribute significantly to improved clinical management of women receiving breast magnetic resonance imaging (MRI) by achieving diagnostic performance comparable to or better than dynamic contrast-enhanced (DCE) breast MRI alone.
The purpose of this clinical trial is to evaluate the addition of MRg-NIRS with and without contrast in 20 women with breast cancer. The women enrolled in the trial will be those who have a newly diagnosed breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 83 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females age ≥ 18 years old
- •Participants capable of providing written informed consent
- •Women with a recent diagnosis of breast cancer.
- •Women who are in pre-surgical planning must have an estimated tumor size of 2.0 cm or less on available imaging.
- •Women who are in pre-surgical planning must have had a breast biopsy at least 10 days prior to the MRg-NIRS exam.
排除标准
- •Participants with absolute or relative contraindication to MRI:
- •the presence of an electronic implant, such as a pacemaker
- •the presence of a metal implant, such as an aneurysm clip
- •claustrophobia
- •renal failure (FDA's guidance for gadolinium of a creatinine clearance less than 30 mL/1.73 m2 BSA)
- •Pregnant women
- •Breast implants
- •Participants with visually inadequate healing from breast biopsy.
研究组 & 干预措施
MR-guided NIRS
The MRg-NIRS device will be tested to see if it accommodates different breast sizes, covers the breast fully, includes the axilla, is compatible with commercial breast MRI coil and/or biopsy systems, and the signal-to-noise ratio is high enough for MRg-NIRS image reconstruction.
The study team will collect MRI-derived ROI data with T1, T2 and DCE-MRI sequences from 20 women with breast abnormalities and NIRS data concurrently. The study team will also collect diffuse optical signals at 48x48 detector source positions over one side of breast at 6 wavelengths.
干预措施: MRg-NIRS (Device)
结局指标
主要结局
Optical sensitivity of the MRg-NIRS platform
时间窗: up to one hour on day of MRI
Optical data sensitivity will be measured (The sensitivity of the measurements to a given region identified by MRI, Sr, will be calculated as the sum of the log of the Jacobian times vector r. Here, r is a logical vector that identifies points within the region of interest and J is the Jacobian, the rate of change of measurements to a change in optical properties at a location in the region identified).
次要结局
- Diagnostic performance of the MRg-NIRS platform(up to one hour on day of MRI)
研究者
Keith D. Paulsen
Professor of Engineering
Dartmouth-Hitchcock Medical Center