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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Procedure: therapeutic conventional surgery
* Radiation: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDG PET/CT<br>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. | Procedure: therapeutic conventional surgery<br> <br> Radiation: fludeoxyglucose F 18<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | Diagnostic Accuracy measures will be calculated using ROC analysis, subset by anatomic location | Within Two Weeks Before Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, stage II verrucous carcinoma of the oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, tongue cancer