NCT00783757已完成不适用
Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer
Steven Isakoff, MD, PhD2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年8月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To explore the feasibility of measuring optically derived parameters in the clinical setting.
研究概览
简要总结
The purpose of this research study is to see if Near-Infrared Tomographic Optical Breast Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in breast tissue.
详细描述
- Participants will have a TOBI scan prior to starting their cancer treatment and again on day 8 after their first treatment. Participants will also be asked if they would volunteer to undergoing one or more additional TOBI scans on days 2-7 after they begin cancer treatment. These additional scans are optional. Participants will also have a scan on the first day of each treatment cycle.
- TOBI scans will be performed at the Gillette Center for Breast Cancer at the Massachusetts General Hospital.
- For the scan, each breast is placed between 2 plastic plates in order to spread the tissue apart, similar to the procedure for a mammogram. The TOBI scanner is attached to these plates. We will apply mild pressure to compress the breast and the breast will be scanned using light waves. Each scan will take about 3 minutes.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients presenting to the MGH Cancer Center Gillette Center for breast cancer neoadjuvant therapy
- •Subject who have had or will have a clinically indicated pre-treatment breast MRI
排除标准
- •Younger than 18 years of age
- •Open wounds on breast
- •Breast implants, because they may interfere with readings
- •Subjects who will be receiving preoperative therapy for <28 days
- •Breast surgery or biopsy < 10 days prior to optical imaging scan
- •Medical or psychiatric or other medical condition that the principal investigator believes may result in inability to complete the study
- •Bilateral breast cancers or a history of contralateral breast cancer
研究组 & 干预措施
Optical Imaging
Experimental
Tomographic Optical Imaging Arm
干预措施: Optical Imaging (Device)
结局指标
主要结局
To explore the feasibility of measuring optically derived parameters in the clinical setting.
时间窗: 4 years
次要结局
- To explore the changes before and after neoadjuvant therapy of additional parameters derived from dynamic and static optical imaging of primary breast cancer.(4 years)
- To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer.(4 years)
研究者
Steven Isakoff, MD, PhD
Attending Physician
Massachusetts General Hospital
研究点 (2)
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