A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Solid Tumors and Lymph Nodes (MSOT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events Due to MSOT Imaging
研究概览
简要总结
The purpose of this study is to evaluate the safety and potential of a new experimental imaging instrument called multispectral optoacoustic tomography (MSOT) to detect tumors and lymph nodes with tumors.
详细描述
This study will involve patients that are scheduled for routine standard of care surgery. It is a single-arm study designed to provide safety information regarding the use of the Acuity MSOT device in the clinical setting, and the ability of MSOT imaging data to correlate with clinical findings identified via pathology.
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 record. All images will be obtained pre- and post-surgery in a closed surgical patient. The temperature of the patient's skin will also be measured prior to and after MSOT imaging. MSOT imaging 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
- 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
- •Patients with an identified solid tumor, i.e. breast (Stage I-IV), melanoma (Stage I-IV), HNSCC (Stage I-III), pancreatic (Stage I-III), ovarian (Stage I-IV) that is scheduled for surgical removal of the tumor and completed standard imaging prior to surgery
- •Have acceptable hematologic status [total hemoglobin (tHb) ≥ 10 mg/dL]
- •Patients ≥ 18 yrs of age
- •Patient provided a signed and dated informed consent
- •Willing to comply with study procedures and be available for the duration of the study
- •Ability to understand and the willingness to sign an IRB-approved informed consent document.
排除标准
- •Patients with central nervous system tumors
- •Patients with a tattoo over the surgical site
- •Pregnant women
- •Women who are breastfeeding
- •Systemic or local infection
- •Any systemic anomaly during the pre-op assessment preventing patient participation in the study
- •Any febrile illness that precludes or delays participation preoperatively
- •Anything that would put the participant at increased risk or preclude compliance with the study
- •Patients with Stage IV pancreatic cancer, Stage IV HNSCC are not surgical candidates and therefore excluded from this study
结局指标
主要结局
Number of Participants With Adverse Events Due to MSOT Imaging
时间窗: 1-2 minutes
Adverse events as characterized by CTCAE v5.0 in patients that may result from MSOT imaging (≥44 degrees Celsius). Measurement of skin temperature pre- and post-MSOT imaging (2 measurements total) with a touch thermometer as part of the safety evaluation of the MSOT device. The thermometer will be placed onto the skin until a temperature appears, about 1 minute, and the temperature will be recorded.
Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery)
时间窗: 1-2 minutes after imaging
Percent of patients who experienced skin temperature readings \>44 degrees Celsius.
次要结局
- Tumor Positivity From Pathology Reports Compared to MSOT Readings(6 months)
- Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device.(6 months)
- Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT(6 months)