FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Procedure: therapeutic conventional surgeryRadiation: fludeoxyglucose F 18
- Registration Number
- NCT00983697
- Lead Sponsor
- American College of Radiology Imaging Network
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 292
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FDG PET/CT therapeutic conventional surgery 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. FDG PET/CT fludeoxyglucose F 18 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.
- Primary Outcome Measures
Name Time Method Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes 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.
- Secondary Outcome Measures
Name Time Method 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 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
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 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
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 The outcome measure will use the total cost of care for each participant to compute the incremental cost-effectiveness ratio (ICER)
Incidence of occult distant body metastasis discovered by whole body PET/CT imaging Within Two Weeks Before Surgery this outcome will count the distant body metastasis not previously seen and report the results as a percentage.
Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results 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
Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction Within Two Weeks Before Surgery the metastatic disease status is the response variable and PET/CT test results and biomarker data are predictors.
Quality of life (QOL), particularly in patients whose management could have been altered by imaging results 2 years post-surgery QOL will be assessed using SF-36, Non-Utility HUI, and UW-QoL scores
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 model the associations of PET/CT test results and biomarker data (predictors) to recurrence
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 model the associations of PET/CT test results and biomarker data (predictors) to overall survival (censored responses)
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 model the associations of PET/CT test results and biomarker data (predictors) to disease-free survival
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 Outcome is defined as the number patients who surgeons intend to dissect levels beyond the initial surgery plan
Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging 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
Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location) Within Two Weeks Before Surgery Diagnostic Accuracy measures will be calculated using ROC analysis, subset by anatomic location
Trial Locations
- Locations (12)
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Peking Union Medical College Hospital
🇨🇳Beijing, China
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States
Morton Plant Mease Cancer Care at Mease Countryside Hospital
🇺🇸Safety Harbor, Florida, United States
Jewish Hospital Heart and Lung Institute
🇺🇸Louisville, Kentucky, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States