Status:
UNKNOWN
FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer
Lead Sponsor:
American College of Radiology Imaging Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 be...
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 ne...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT00983697
Start Date
April 1 2010
End Date
December 1 2021
Last Update
October 23 2020
Active Locations (12)
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1
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
3
Morton Plant Mease Cancer Care at Mease Countryside Hospital
Safety Harbor, Florida, United States, 34695
4
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497