A Pilot Study of Photoacoustic Imaging (PAI) in H&N Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate
研究概览
简要总结
This trial studies how well photoacoustic imaging works in measuring tumors and normal tissue in patients with head and neck cancer. Photoacoustic imaging (PAI) is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. This study may help doctors determine if PAI is correlated with clinical responses of both tumor (for example: shrinking, swelling or disappearing) and normal tissues (for example: skin redness, dry mouth, appearance of sores, healing of skin or mucosa). If there is a correlation with clinical responses, then doctors may develop PAI as method for measuring response to earlier treatment.
详细描述
PRIMARY OBJECTIVE:
I. Define the feasibility of the current photoacoustic imaging (PAI) technology in head and neck (H&N) cancer patients.
SECONDARY OBJECTIVE:
I. Define the utility of the current PAI in H&N cancer patients.
OUTLINE:
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
- 否
入选标准
- •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
- •FOR CANCER PATIENTS IN THE H&N RADIATION GROUP (PART I):
- •Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) getting chemoradiation therapy
- •Presence of neck nodes or laryngeal tumor superficial enough (within 2-3 cm of skin surface) to allow imaging by photoacoustic ultrasound (PA-US)
- •FOR ALTENS PATIENTS (PART II):
- •History of prior radiation therapy with xerostomia requiring ALTENS
排除标准
- •Uncontrolled intercurrent 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
研究组 & 干预措施
Diagnostic (PAI, ALTENS)
PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy.
PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up.
干预措施: Photoacoustic Imaging (Procedure)
Diagnostic (PAI, ALTENS)
PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy.
PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up.
干预措施: Transcutaneous Acupoint Electrical Stimulation (Procedure)
结局指标
主要结局
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate
时间窗: Up to 6 months after treatment completion
Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
Feasibility of PAI to quantify tumor characteristic in patients undergoing ALTENS (part II): rate
时间窗: Up to 2 years
Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
次要结局
- Changes in hemoglobin (hbt) measurements(Up to 2 years)
- Utility of serial PAI-based oxygen saturation (%sO2) measurements(Up to 2 years)