Surgeon-performed Outpatient Transoral and Transcervical Ultrasound Compared to MRI for the Diagnostic Workup of Primary Oropharynx Tumors: the SPOT-US Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 6
- 主要终点
- Tumors detected by clinical evaluation, ultrasound, MRI, CT, and PET/CT compared to the reference standard histopathology results.
研究概览
简要总结
The purpose of the study is to compare the sensitivity and specificity of transoral ultrasound, transcervical ultrasound, Magnetic Resonance Imaging (MRI) and Positron Emission Tomography-Computerized Tomography (PET-CT) in terms of detecting primary oropharynx tumors.
详细描述
A prospective study will be performed at the head & neck departments at Copenhagen University Hospital - Rigshospitalet, Zealand University Hospital - Køge, and Aarhus University Hospital in Denmark.
Patients referred with a suspected cancerous lesion of the oropharynx will be invited to participate in this study. With written informed consent, a surgeon-performed outpatient transoral and transcervical examination of the tonsils and tongue base is conducted as an addition to the clinical workup at the head & neck departments. Clinical work-up includes palpation of the oropharynx, flexible endoscopic exam with narrow-band imaging and neck ultrasound.
Ultrasound of the oropharynx will be performed using small-footprint, high-frequency (minimum 15MHz) transducers for transoral ultrasound. A lower-frequency (between 2-9 MHz) curved transducer will be used for transcervical ultrasound. If a suspected tumor is visualized, the location is noted and the surgeon performing clinical examination is informed.
MRIs will be performed on all patients with cancers, and an expert radiologist blinded to ultrasound results will assess all images for tumor detection, greatest tumor size and T-stage. PET/CTs will be performed in patients with suspected cancer of unknown primary tumor as well as patients with verified cancers. A nuclear medicine physician and an oncoradiologist will separately assess PET/CTs and CTs for tumor detection.
Surgeons performing initial clinical work-up, the ultrasound operators, neuroradiologist and nuclear medicine physician will register tumor detection (sub-location specific) and greatest tumor size immediately and prospectively, blinded to histopathology. Prospective gathered data will be registered on standardized data collection sheets or in REDCap using the same standardized variables. All scanning modalities will be evaluated blinded to each other but not to clinical findings.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Tumors detected by clinical evaluation, ultrasound, MRI, CT, and PET/CT compared to the reference standard histopathology results.
时间窗: 2 weeks.
Sub-location specific detection of tumors in the oropharynx will be assessed blinded to histopathology. The final histopathology diagnosis will typically be available within two weeks.
次要结局
- Greatest tumor diameter in millimeters estimated with clinical evaluation, ultrasound and MRI, and CT.(1 minute)
- Categorical T-stage estimated with clinical evaluation, ultrasound, and MRI, and CT.(1 minute)
- Tonsil and tongue base tumor volume estimated with clinical evaluation, ultrasound and MRI, and CT.(1 minute)
研究者
Martin Garset-Zamani, MD
Principal Investigator
Rigshospitalet, Denmark