FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
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
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: laboratory biomarker analysis Type: Other
Name: quality-of-life assessment Type: Procedure
Name: therapeutic conventional surgery Type: Procedure
Name: fludeoxyglucose F 18 Type: Radiation
Overall Status
Recruiting
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Status: Recruiting
Contact: Brendan Stack, MD - 501-686-5140
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Status: Recruiting
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente - 323-865-0451
Morton Plant Mease Cancer Care at Mease Countryside Hospital
Safety Harbor, Florida, United States
Status: Recruiting
Contact: Yair Safriel, MD - 727-461-8885
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Status: Recruiting
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese - 800-456-7121 - canceranswers@moffitt.org
Jewish Hospital Heart and Lung Institute
Louisville, Kentucky, United States
Status: Recruiting
Contact: Robert Falk, MD - 502-583-2731
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Status: Recruiting
Contact: Clinical Trials Office - All Mayo Clinic Locations - 507-538-7623
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Farrokh Dehdashti, MD - 314-747-1624
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Carol Geer, MD - 336-716-4687
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Laurie Loevner, MD - 215-662-7273
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi - 215-728-4790
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Charles Intenzo, MD - 215-955-8606
Peking Union Medical College Hospital
Beijing, China
Status: Recruiting
Contact: Fang Li, MD - 86-10-6529-5505
Start Date
April 2010
Sponsors
American College of Radiology Imaging Network
Source
American College of Radiology Imaging Network
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page