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

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.

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