A Pilot Study of Photoacoustic Imaging (PAI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics
研究概览
简要总结
This pilot trial studies how well photoacoustic imaging works in diagnosing changes in tumors in participants with breast cancer, sarcoma, skin cancer, or soft tissue malignancy and healthy volunteers. Photoacoustic imaging is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. Photoacoustic imaging uses a signal from hemoglobin to provide information on blood flow and oxygen levels, and it may be helpful in determining changes in tumors after chemotherapy or radiation treatment.
详细描述
PRIMARY OBJECTIVES:
I. To define the feasibility of the current photoacoustic imaging (PAI) technology in various groups of human subjects.
SECONDARY OBJECTIVES:
I. To define the utility of the current PAI on various groups of human subjects.
II. When possible, via means of an existing data review, PAI will be correlated with standard imaging modalities performed on patients as routine part of clinical care or on protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ALL GROUPS:
- •No restriction on race or ethnic background.
- •Subject must understand the investigational nature of the study and sign an independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure.
- •HEALTHY VOLUNTEERS:
- •No history of antimicrobial therapy or drug treatment including anti-hypertensive, diuretic, immunosuppressive or anti-depressant drugs in the previous 6-month period.
- •No history of diabetes.
- •No history of cancer to the body site to be imaged.
- •BREAST, SARCOMA, SKIN CANCER, AND SUPERFICIAL MALIGNANCY PATIENTS:
- •Biopsy-proven aforementioned malignancy.
- •SURGICAL FLAP PATIENTS:
- •Need for plastic surgery reconstruction with a free or rotational flap.
排除标准
- •Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Unwilling or unable to follow protocol requirements or provide consent.
- •Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
结局指标
主要结局
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics
时间窗: Up to 6 months
This will be deemed a success if at least 3 imaging sessions produce a usable image. Usable datasets will be defined as those images with detectable PAI signal with minimal or no artifacts within the region of interest. This analysis will be done in the imaged sample, consisting of enrolled patients who attempt at least one imaging session. Patients who do not attempt at least one imaging session will be replaced.
次要结局
- Utility of serial PAI measurements(Up to 6 months)
- Serial PAI oxygenation measurements(Up to 6 months)