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
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 292
- 试验地点
- 12
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed squamous cell carcinoma (SCC) of the head and neck , including any of the following sites:
- •Oral cavity
- •Oropharynx, including base of tongue and tonsils
- •Supraglottis
- •Stage T2-T4, N0-N3 disease
- •Unilateral or bilateral neck dissection planned
- •No N2c disease (if bilateral disease is present)
- •Has ≥ 1 clinically N0 neck side as defined by clinical exam (physical exam with CT scan and/or MRI)
- •A N0 neck must be planned to be dissected for the patient to be eligible
- •. The N0 neck can be either ipsilateral to the head and neck tumor or the contralateral N0 neck if a bilateral neck dissection is planned
- •CT scan and/or MRI taken within the past 4 weeks to confirm SCC of the head and neck
- •Simultaneous diagnostic CT with PET scan allowed; however, PET cannot be used as part of the criteria to define the N0 neck disease
- •For CT scan and/or MR images from other institutions, ACRIN recommends a re-read by a local neuro-radiologist to ensure compliance
- •No sinonasal cancer, salivary gland cancer, thyroid cancer, nasopharyngeal cancer, or advanced skin cancer
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Negative pregnancy test
- •Weight ≤ 350 lbs
- •No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications (optimally, patients will have glucose < 150 mg/dL)
- •No underlying medical condition that would preclude surgery (neck dissection)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
FDG PET/CT
Experimental
Planning for Therapeutic conventional surgery of the N0 neck is documented prior to and immediately after review of the fludeoxyglucose F 18 (FDG)-PET/CT scan completed per protocol.
干预措施: therapeutic conventional surgery (Procedure)
FDG PET/CT
Experimental
Planning for Therapeutic conventional surgery of the N0 neck is documented prior to and immediately after review of the fludeoxyglucose F 18 (FDG)-PET/CT scan completed per protocol.
干预措施: fludeoxyglucose F 18 (Radiation)
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
- Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction(Within Two Weeks Before Surgery)
- 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)
- 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)
- Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results(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 (12)
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