Infrared Imaging for Breast Cancer Modeling
The primary objective of this study is to obtain infrared (IR) images and video and three-dimensional (3-D) scans of patients referred for biopsy based on the results of their diagnostic breast exam(s).
This research study is investigating infrared imaging (also referred to as infrared thermography, or digital infrared thermal imaging (DITI)) of breast cancer. The infrared images collected in this study will be used to construct a computational biothermal engineering model of the cancerous breast.
Patients will undergo standard breast cancer screening procedures as part of routine care at Parkland Comprehensive Breast Center. For any patients who are referred for biopsy based on the results of their breast cancer screening procedures, this research study will take infrared images of the patient. Patients will undergo infrared imaging prior to biopsy but will not delay biopsy or treatment; infrared images & video may be recorded at biopsy visit. The biopsy will confirm/diagnose whether the patient has a benign or malignant condition.
研究概览
详细说明
The purpose of this research study is to obtain IR images, IR video, and 3-D scans of female patients' breasts (i.e., thermograms) who have been referred for biopsy based on the results of their diagnostic breast exams. These patients may be later diagnosed with a malignant or benign breast condition. The infrared images and video collected will be used to construct and validate a computational biothermal engineering model of breast cancer.
This research study does not involve any investigational drugs or treatments. This research study does not involve any FDA-approved drugs or devices.
In this research study, the equipment used (IR camera, 3-D scanner) will no be tested nor be used to diagnose or treat. Further, medical decisions will not be based on the use of these devices.
Infrared imaging (or digital thermal infrared imaging, DITI) is a non-invasive, non-contact, and harmless imaging procedure that measures the natural infrared radiation (body heat) emitted by the human body at normal 37°C body temperature. This procedure does not expose the patient to any radiation and is therefore entirely safe for the patient.
IR images and video will be obtained by IR equipment provided by University of Texas (UT) at Dallas researchers. IR equipment consists of an IR camera and ancillary equipment (e.g., tripod, computer, and vendor-provided IR image-processing software). The IR camera that will be used will be a commercial off-the-shelf product.
Additionally, a 3-D scanner will be used to obtain a 3-D surface contour map of the patient's breasts. This 3-D scanner is also non-invasive, non-contact, and does not expose the patient any radiation, similar to the IR camera. The 3-D scanner outputs a file format that is compatible with 3-D computer-aided design (CAD) software for engineering analysis.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Dallas、Texas、美国、75235
- Parkland Memorial Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Females with a suspicious breast mass (BI-RADS 4C or 5).
- Referred for a breast biopsy.
- Capable of providing informed consent.
Exclusion Criteria:
- Currently undergoing treatment for breast cancer.
- Incapable of providing informed consent.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Patients referred for breast biopsy
Patients with Breast Imaging-Reporting and Data System (BI-RADS) 4C or 5 diagnosis who have been referred for breast biopsy based on the results of their standard diagnostic breast exam will undergo IR and 3D imaging of the breasts.
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Subjects will undergo steady steady state and video IR imaging of the breasts.
Subjects will undergo 3D scanning of the breasts.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Spatial location of breast tumors
大体时间:Two years
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Researchers will use subjects' radiological imaging data to quantify the location of the tumor inside the breast, including mammography, ultrasound, and/or magnetic resonance imaging (MRI), for patients who are diagnosed with breast cancer.
The tumor location will be measured.
The tumor location will serve as an input for the computational model.
No diagnostic assessments will be made from these data for this research study.
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Two years
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3-D Surface contour maps of the breast
大体时间:Two years
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Researchers will use a 3-D scanning device to reconstruct the 3-D surface geometry of subjects' breasts.
The surface geometry of subjects' breasts will be measured.
The surface geometry will serve as an input for the computational model.
No diagnostic assessments will be made from these data for this research study.
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Two years
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Computational thermal model of breast cancer
大体时间:Two years
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Researchers will use study data to validate a computational biothermal engineering model of the cancerous breast.
The computational model will model and simulate the internal thermodynamic and heat transfer processes inside the breast with cancer.
The model outputs expected surface temperatures of the breast with cancer.
The model will be constructed using commercial engineering software, ANSYS Fluent.
No diagnostic assessments will be made from these data for this research study.
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Two years
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合作者和调查者
调查人员
- 首席研究员:Jody Hayes, MD、UT Southwestern Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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