Multispectral Optoacoustic Tomography for the Detection of Extranodal Extension and Radiation Induced Fibrosis in Head and Neck Squamous Cell Cancer
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Adverse events due to MSOT imaging prior to radiotherapy
研究概览
简要总结
The purpose of this research is to assess the safety and evaluate the potential of the Multispectral Optoacoustic Tomography (MSOT) device to more precisely identify and assess the neck lymph nodes which might be affected in patients with metastatic head and neck squamous cell carcinomas.
详细描述
This is a 2-Arm investigational device study designed to provide safety information regarding the use of the Acuity MSOT device in the clinical setting, and to determine the ability of MSOT imaging data to correlate with clinical findings identified via pathology. Imaging with the MSOT device is expected to obtain information about the number, size, and appearance of the lymph nodes in the neck. The device will be used to obtain images of the tumor or lymph node margins for investigational use only to compare to clinical pathology and patient's medical records. All images will be obtained pre-surgery for Arm 1 patients (undergoing surgery for their cancer) and before, during and after radiotherapy in Arm 2 patients (undergoing radiotherapy treatment for their cancer). The temperature of the patient's skin will also be measured prior to and after each MSOT scan. Once radiotherapy treatment has completed, images using the MSOT device will be obtained every 6 months for 2 years to assess for radiation induced fibrosis. MSOT scans will be for research only and no treatment decisions will be based on the MSOT images obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Clinically confirmed node positive head and neck squamous cell cancer
- •Written informed consent signed and dated by the patient prior to the performance of the MSOT
- •At least 18 years-of-age at the time of signature of the informed consent form (ICF)
- •Patients planned for curative intent therapy
- •Patient available for the study duration
- •Patients of childbearing potential must have a negative pregnancy test prior to the study entry.
- •Patients of childbearing potential must use an effective form of contraceptive as per the protocol.
排除标准
- •History of previous head and neck radiotherapy
- •Intent of treatment palliative
- •Women who are pregnant
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety of efficacy assessment of the investigational regimen should be included.
- •Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
研究组 & 干预措施
Arm 1 - surgery patients
70 patients with clinically confirmed metastatic head and neck squamous cell carcinomas (N+ HNSCC) planned for definitive surgery will be imaged using the MSOT device prior to surgery. Skin temperature will be measured prior to and after MSOT imaging to assess for safety.
干预措施: Temperature Measurement (Procedure)
Arm 2 - radiotherapy patients
30 patients with clinically confirmed metastatic head and neck squamous cell carcinomas (N+ HNSCC) planned for definitive radiotherapy (RT) (+/- chemo) will be imaged using the MSOT device before, during, and after radiotherapy. 15 patients will be treated with photon RT and 15 patients will be treated with proton therapy. Skin temperature will be measured prior to and after MSOT imaging to assess for safety.
干预措施: Multispectral Optoacoustic Tomography (Device)
Arm 2 - radiotherapy patients
30 patients with clinically confirmed metastatic head and neck squamous cell carcinomas (N+ HNSCC) planned for definitive radiotherapy (RT) (+/- chemo) will be imaged using the MSOT device before, during, and after radiotherapy. 15 patients will be treated with photon RT and 15 patients will be treated with proton therapy. Skin temperature will be measured prior to and after MSOT imaging to assess for safety.
干预措施: Temperature Measurement (Procedure)
Arm 1 - surgery patients
70 patients with clinically confirmed metastatic head and neck squamous cell carcinomas (N+ HNSCC) planned for definitive surgery will be imaged using the MSOT device prior to surgery. Skin temperature will be measured prior to and after MSOT imaging to assess for safety.
干预措施: Multispectral Optoacoustic Tomography (Device)
结局指标
主要结局
Adverse events due to MSOT imaging prior to radiotherapy
时间窗: 30 minutes for an MSOT image (up to 24 hours post-image)
Proportion of patients that experience adverse events resulting from MSOT imaging. The first MSOT image will be taken prior to radiotherapy.
Adverse events due to MSOT imaging during week 4 of radiotherapy
时间窗: 30 minutes for an MSOT image (up to 24 hours post-image)
Proportion of patients that experience adverse events resulting from MSOT imaging. The second MSOT image will be taken during week 4 of radiotherapy for patients enrolled in Arm 2.
Measurement of skin temperature before MSOT imaging
时间窗: 1-2 minutes before the MSOT image.
Number of patients with skin temperatures measured pre-MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) before the MSOT image is obtained.
Measurement of skin temperature after MSOT imaging
时间窗: 1-2 minutes after the MSOT image
Number of patients with skin temperatures measured post-MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) after the MSOT image is obtained.
Adverse events due to MSOT imaging prior to surgery
时间窗: 30 minutes for an MSOT image (up to 24 hours post-image)
Proportion of patients that experience adverse events resulting from MSOT imaging. The first MSOT image will be taken prior to surgery
Adverse events due to MSOT imaging after the completion of radiotherapy treatment.
时间窗: 30 minutes for an MSOT image (up to 24 hours post-image)
Proportion of patients that experience adverse events resulting from MSOT imaging. The third MSOT image will be taken after conclusion of radiotherapy for patients enrolled in Arm 2.
次要结局
- Assessment of radiation induced fibrosis via MSOT imaging in first follow up scan for Arm 2(30 minutes for an MSOT image (up to 24 hours post-image))
- Assessment of radiation induced fibrosis via MSOT imaging in fourth follow up scan for Arm 2(30 minutes for an MSOT image (up to 24 hours post-image))
- Assessment of radiation induced fibrosis via MSOT imaging in second follow up scan for Arm 2(30 minutes for an MSOT image (up to 24 hours post-image))
- Assessment of radiation induced fibrosis via MSOT imaging in third follow up scan for Arm 2(30 minutes for an MSOT image (up to 24 hours post-image))
- Degree of bias for the comparison of MSOT images with CT scans (or other imaging modalities if necessary)(2 years)