NCT00983697Unknown不适用
A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 292
- 试验地点
- 24
- 主要终点
- Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET/CT scan, may help doctors find head and neck cancer and find out how far the disease has spread. It may also help doctors plan the best treatment.
PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing the tumor and planning neck surgery in patients with newly diagnosed head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Determine the negative predictive value of PET/CT imaging based upon pathologic sampling of the neck lymph nodes in patients with head and neck cancer planning to undergo N0 neck surgery.
- Determine the potential of PET/CT imaging to change treatment.
Secondary
- Estimate the sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinical N0 neck (both by neck and lymph node regions) or other local sites.
- Determine the effect of other factors (e.g., tumor size, location, secondary primary tumors, or intensity of FDG uptake) that can lead to identification of subsets of patients that could potentially forego neck dissection or that can provide preliminary data for subsequent studies.
- Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer vs current good clinical practices.
- Evaluate the incidence of occult distant body metastasis discovered by whole-body PET/CT imaging.
- Correlate PET/CT imaging findings with CT/MRI findings and biomarker results.
- Evaluate the quality of life of these patients, particularly of those patients whose management could have been altered by imaging results.
- Evaluate PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction.
- Compare baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence, disease-free survival, and overall survival.
- Determine the proportion of neck dissections that are extended (i.e., additional levels that clinicians intend to dissect beyond the initial surgery plan) based on local-reader PET/CT imaging findings shared with the surgeon before dissection.
- Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging.
- Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location).
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
Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes
时间窗: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
True negative cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise.
次要结局
- Sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinically N0 neck (both by neck and lymph node regions) or other local sites(Within Two Weeks Before Surgery and after sampling of neck lymph nodes)
- Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results(Within Two Weeks Before Surgery)
- Determine which factors (e.g., tumor size, secondary primary tumors, location, or intensity of FDG uptake) may identify patients who can forego neck dissection(Within Two Weeks Before Surgery and after sampling of neck lymph nodes)
- Cost-effectiveness and cost-benefit of using PET/CT imaging for staging of head and neck cancer vs current good clinical practices(2 years post-surgery)
- Incidence of occult distant body metastasis discovered by whole body PET/CT imaging(Within Two Weeks Before Surgery)
- Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction(Within Two Weeks Before Surgery)
- Quality of life (QOL), particularly in patients whose management could have been altered by imaging results(2 years post-surgery)
- Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence(2 years post-surgery)
- Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of overall survival(2 years post-surgery)
- Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of disease-free survival(2 years post-surgery)
- Proportion of neck dissections that are extended based on local-reader PET/CT imaging findings shared with the surgeon before dissection(Within Two Weeks Before Surgery)
- Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging(Within Two Weeks Before Surgery)
- Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location)(Within Two Weeks Before Surgery)
研究者
研究点 (24)
Loading locations...
相似试验
已完成
不适用
PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During SurgeryColorectal CancerNCT00004891Memorial Sloan Kettering Cancer Center149
已完成
3 期
Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin LymphomaLymphomaNCT00678327University College, London1,202
已完成
不适用
Utility of PET In the Pre-Operative Assessment of Patients With Hepatic Colorectal MetastasesColorectal CarcinomaNCT00588549Memorial Sloan Kettering Cancer Center204
已完成
不适用
The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders (The PETVET Study)Venous Thromboembolic DiseaseNCT01466426Odense University Hospital40
Unknown
4 期
Evaluation of PET CT in the Management of Patients With Crohn's Disease.Crohn's DiseaseNCT00731809Rabin Medical Center50