Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to Assess Lymph Node Metastases in Head and Neck Cancer: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy
研究概览
简要总结
For patients undergoing treatment for head and neck cancer, this study will use dynamic contrast-enhanced CT scans to try to determine which lymph nodes in the neck contain cancer and require surgical removal.
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
- •Age 18 or older
- •Willing to provide informed consent
- •ECOG performance status 0-2
- •Histologically confirmed squamous cell carcinoma (includes variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS) of the head and neck
- •Tumor stage: Any (T1-T4)
- •Nodal stage:
- •N2 or N3 (≥ 3 cm) on pre-treatment imaging for radiotherapy cohort (higher likelihood of requiring neck dissection);
- •N1-N3 for surgery cohort. N0 admissible for T4 tumors.
- •Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon), with recommendation for definitive chemoradiation therapy (n=15) or surgery (n=15)
排除标准
- •Prior history of head and neck cancer within 5 years
- •Prior head and neck radiation at any time
- •Metastatic disease, or imaging findings suspicious for metastases
- •Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer.
- •Pregnant or lactating women
- •Contraindication to DCE-CT (e.g. contrast allergy)
研究组 & 干预措施
Surgical patients
This group will consist of 15 patients with locally advanced HNSCC of the oral cavity, larynx or hypopharynx presenting with adenopathy ≥ 1 cm where the recommended treatment is surgical resection of the primary malignancy with bilateral neck dissection. These patients will receive a DCE-CT scan of the head and neck prior to surgery.
干预措施: Dynamic Contrast Enhanced CT scan (Radiation)
Chemoradiation Patients
This group will consist of 15 patients with locally advanced HNSCC with lymph nodes ≥3 cm in which chemoradiotherapy is the primary treatment as per standard of care. This group will be composed of patients with a primary malignancy originating in the nasopharynx, oropharynx, hypopharynx or larynx. Pre-treatment DCE-CT of neck will be obtained. The standard therapy, radiation and chemotherapy, will be administered and the patients will have standard follow up. A post-treatment DCE-CT of neck will be obtained 8-10 weeks after treatment along with standard CT neck.
干预措施: Dynamic Contrast Enhanced CT scan (Radiation)
结局指标
主要结局
Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy
时间窗: 8-10 weeks post treatment
次要结局
- Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery(Approximately 2-6 weeks after enrollment)
研究者
David Palma
Radiation Oncologist/Clinician Scientist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's