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FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer (ACRIN6685)

2020年10月22日 更新者：American College of Radiology Imaging Network

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

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.

研究概览

地位

未知

条件

干预/治疗

详细说明

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).

OUTLINE: This is a multicenter study.

Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients undergo unilateral or bilateral neck dissection.

Patients complete quality-of-life questionnaires at baseline and at 1, 12, and 24 months after surgery.

Patients undergo blood and tissue sample collection periodically for biomarker analysis.

Patients are followed up periodically for up to 2 years after surgery.

研究类型

介入性

注册 (预期的)

292

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100730
        • Peking Union Medical College Hospital
  • 美国
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Los Angeles、California、美国、90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
    • Florida
      • Safety Harbor、Florida、美国、34695
        • Morton Plant Mease Cancer Care at Mease Countryside Hospital
      • Tampa、Florida、美国、33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Kentucky
      • Louisville、Kentucky、美国、40245
        • Jewish Hospital Heart and Lung Institute
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • North Carolina
      • Winston-Salem、North Carolina、美国、27157
        • Wake Forest University Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia、Pennsylvania、美国、19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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
    • Larynx
    • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：FDG PET/CT
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.
程序：治疗性常规手术
辐射：氟脱氧葡萄糖 F 18

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes
大体时间：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.
Within Two Weeks Before Surgery and after sampling of neck lymph nodes

次要结果测量

结果测量
措施说明
大体时间
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
大体时间：Within Two Weeks Before Surgery and after sampling of neck lymph nodes
True positive cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise. The diagnostic yield is defined as the ratio of cancers to total screened
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
大体时间：Within Two Weeks Before Surgery and after sampling of neck lymph nodes
True positive cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise. The diagnostic yield is defined as the ratio of cancers to total screened
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
大体时间：2 years post-surgery
The outcome measure will use the total cost of care for each participant to compute the incremental cost-effectiveness ratio (ICER)
2 years post-surgery
Incidence of occult distant body metastasis discovered by whole body PET/CT imaging
大体时间：Within Two Weeks Before Surgery
this outcome will count the distant body metastasis not previously seen and report the results as a percentage.
Within Two Weeks Before Surgery
Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results
大体时间：Within Two Weeks Before Surgery
the outcome measure will consist of paired proportions of dichotomized PET/CT and CT/MRI test results; and biomarker test results
Within Two Weeks Before Surgery
Quality of life (QOL), particularly in patients whose management could have been altered by imaging results
大体时间：2 years post-surgery
QOL will be assessed using SF-36, Non-Utility HUI, and UW-QoL scores
2 years post-surgery
Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction
大体时间：Within Two Weeks Before Surgery
the metastatic disease status is the response variable and PET/CT test results and biomarker data are predictors.
Within Two Weeks Before Surgery
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence
大体时间：2 years post-surgery
model the associations of PET/CT test results and biomarker data (predictors) to 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 disease-free survival
大体时间：2 years post-surgery
model the associations of PET/CT test results and biomarker data (predictors) to disease-free 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 overall survival
大体时间：2 years post-surgery
model the associations of PET/CT test results and biomarker data (predictors) to overall survival (censored responses)
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
大体时间：Within Two Weeks Before Surgery
Outcome is defined as the number patients who surgeons intend to dissect levels beyond the initial surgery plan
Within Two Weeks Before Surgery
Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging
大体时间：Within Two Weeks Before Surgery
ROC analysis will be used to maximize the youden index and estimate the optimum cutoff value of SUV for diagnostic accuracy of PET/CT on N0 neck
Within Two Weeks Before Surgery
Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location)
大体时间：Within Two Weeks Before Surgery
Diagnostic Accuracy measures will be calculated using ROC analysis, subset by anatomic location
Within Two Weeks Before Surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

American College of Radiology Imaging Network

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Val J. Lowe, MD、Mayo Clinic

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年4月1日

初级完成 (实际的)

2019年1月15日

研究完成 (预期的)

2021年12月1日

研究注册日期

首次提交

2009年9月23日

首先提交符合 QC 标准的

2009年9月23日

首次发布 (估计)

2009年9月24日

研究记录更新

最后更新发布 (实际的)

2020年10月23日

上次提交的符合 QC 标准的更新

2020年10月22日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDR0000654703
  • U01CA080098 (美国 NIH 拨款/合同)
  • U01CA079778 (美国 NIH 拨款/合同)
  • ACRIN-6685 (其他标识符：CIP ID)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

See ACRIN data sharing policy:

https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

IPD 共享时间框架

by request 6+ mo after publication available through The Cancer Imaging Archive expected 1-year after publication.

IPD 共享访问标准

Safe-Harbor deidentified data

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

罕见疾病

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地点

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