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

Head and Neck Cancer Clinical Trial

Official title: 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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

• NCT number: NCT00983697
• Study type: Interventional
• Source: American College of Radiology Imaging Network
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2010
• Completion date: December 2021