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Fludeoxyglucose F 18-PET/CT Imaging in Assessing the Tumor and Planning Neck Surgery in Patients with Newly Diagnosed Head and Neck Cancer
Trial Status: closed to accrual and intervention
This phase II trial is studying fludeoxyglucose F 18-positron emission tomography (PET)/computed tomography (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. Diagnostic procedures, such as fludeoxyglucose F 18 (FDG)-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.
Inclusion Criteria
Participant with histologic confirmation of newly diagnosed squamous cell carcinoma (SCC) of the head and neck
Participant with unilateral or bilateral neck dissection planned for care; an 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
Participant with confirmed head and neck SCC:
* CT and/or MR imaging has been completed within six (6) weeks prior to enrollment, even if the SCC diagnosis has been made via other methods, and will be submitted to American College of Radiology Imaging Network (ACRIN);
* Simultaneous diagnostic CT with PET will not be excluded, but in such cases PET cannot be used as part of the criteria to define the N0 neck as required for entrance to the trial;
* If sites received CT and/or MR images from institutions other than their own, ACRIN recommends a re-read by a local neuroradiologist to ensure compliance with protocol eligibility requirements
Participant with at least one neck that is clinically N0 as defined by clinical exam (physical exam with CT and/or MRI as the gold standard of the N0 neck); stages T2, T3, or T4. N0–N3, excluding N2c for bilateral disease based on criteria from the American Joint Commission on Cancer
Participant in whom it may be considered a viable clinical option to perform neck dissection when primary cancers are at high risk for neck metastasis (see definition above);
* These will include: 1) oral cavity cancer; 2) oropharynx cancer, including base of tongue and tonsil cancers; 3) larynx cancer; or 4) supraglottic cancer
Participant willing to provide a written informed consent
Exclusion Criteria
Patient who is pregnant and/or breastfeeding
Patient with sinonasal carcinoma
Patient with tumors in the head and neck that are not SCC
Patient with salivary gland malignancies
Patient with thyroid cancers
Patient with advanced skin cancers
Patient with nasopharyngeal carcinoma
Patient with poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL; optimally participants will have glucose < 150 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications
Patient not a candidate for surgery (neck dissection) because of an underlying medical condition
Patient who weighs more than the weight limit for the PET table
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00983697.
Locations matching your search criteria
United States
Florida
Dunedin
Morton Plant Mease
Status: Active
Contact: Val J. Lowe
Tampa
Moffitt Cancer Center
Status: Active
Contact: Val J. Lowe
New York
New York
NYP/Weill Cornell Medical Center
Status: Active
Contact: Val J. Lowe
North Carolina
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Val J. Lowe
PRIMARY OBJECTIVES:
I. Determine the negative predictive value (NPV) of PET/CT for staging the N0 neck based upon pathologic sampling of the neck lymph nodes.
II. Determine PET/CT’s potential to change treatment of the N0 neck.
SECONDARY OBJECTIVES:
I. Estimate the 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.
II. 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 patient subsets that could potentially forego neck dissection or provide preliminary data for subsequent studies.
III. Analyze cost-effectiveness of using PET/CT for staging of head and neck cancer versus current good clinical practices.
IV. Evaluate the incidence of occult distant body metastasis discovered by whole body PET/CT.
V. Correlate PET/CT findings to CT/MRI and biomarker results.
VI. Evaluate quality of life (QoL), particularly in participants whose patient management could have been altered by imaging results.
VII. Evaluate the PET/CT and biomarker data for complementary contributions to metastatic disease prediction.
VIII. Compare baseline PET/CT and biomarker data to 2-year follow up as an adjunct assessment of their prediction of recurrence, disease-free survival, and overall survival.
IX. Determine the proportion of neck dissections that are extended—additional levels clinicians intend to dissect beyond the initial surgery plan—based on local-reader PET/CT findings shared with the surgeon prior to dissection.
X. Estimate the optimum cutoff value of standardized uptake values (SUV) for diagnostic accuracy of PET/CT test.
XI. Evaluate the impact of PET/CT on the N0 neck across different tumor subsites (defined by anatomic location).
OUTLINE:
Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients undergo unilateral or bilateral neck dissection.
After completion of study treatment, patients are followed up periodically for up to 2 years.
