Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Malignancies of the Head and Neck, a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Determine margin status in malignancies of the head and neck
研究概览
简要总结
In this study, patients diagnosed with a pathology-proven malignancy of the head and neck will receive a routine clinical activity of 18F-FDG ((18)F-luorodeoxyglucose) before undergoing standard of care surgical resection of the malignancy. Following the resection, the 18F-FDG-infused malignancy will be investigated utilizing a novel high-resolution Positron Emission Tomography (PET) and Computed Tomography (CT) scan. Slicing of the malignancy will be followed by additional PET/CT-scanning and autoradiography of the sliced specimen. The results found during image analysis will be compared to the results of the gold standard of histopathology. As this is no approved way of assessing the tumour's margin, the conclusion of the scan will not be used as a method for changing the patients' treatment.
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 one or multiple pathologically proven malignancies in the head and neck region (targeted lesions), independent of origin and stage.
- •Patient is planned for the surgical resection of the targeted lesion.
- •Age ≥ 18 years.
- •Karnofsky performance scale ≥30
- •Patient has given informed consent according to the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines in accordance with the declaration of Helsinki.
排除标准
- •Patient is planned for a treatment regimen which does not include standard surgical resection of the targeted lesion.
- •Pregnant or actively lactating women.
- •Blood glucose level ≥ 200mg/dl or more on the day of surgery.
结局指标
主要结局
Determine margin status in malignancies of the head and neck
时间窗: 1 week after administration
To investigate the ability of high-resolution 18F-FDG-PET/CT-scan to determine the margin status in malignancies of the head and neck. This will be compared to the gold standard of histopathological examination.
次要结局
- Correlate distribution of 18F-FDG with histopathology(1 day after administration)
- Characterize the ideal activity of 18F-FDG(During data-analysis)
- Identify positive lymph nodes using 18F-FDG PET/CT(1 week after administration)