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

American College of Radiology Imaging Network

Status: Unknown

Conditions: Head and Neck Cancer

Treatments: Radiation: fludeoxyglucose F 18; Procedure: therapeutic conventional surgery

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00983697

U01CA079778 (U.S. NIH Grant/Contract)

ACRIN-6685 (Other Identifier)

U01CA080098 (U.S. NIH Grant/Contract)

CDR0000654703

Details and patient eligibility

About

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.

Full 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.

Enrollment: 292 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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292 participants in 1 patient group

FDG PET/CT

Experimental group

Description:

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.

Treatment:

Radiation: fludeoxyglucose F 18

Procedure: therapeutic conventional surgery