Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Fludeoxyglucose F 18-PET/CT Imaging in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed Head and Neck Cancer

Basic Trial Information

Objectives

Primary

1. 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.
2. Determine the potential of PET/CT imaging to change treatment.

Secondary

1. 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.
2. 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.
3. Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer vs current good clinical practices.
4. Evaluate the incidence of occult distant body metastasis discovered by whole-body PET/CT imaging.
5. Correlate PET/CT imaging findings with CT/MRI findings and biomarker results.
6. Evaluate the quality of life of these patients, particularly of those patients whose management could have been altered by imaging results.
7. Evaluate PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction.
8. 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.
9. 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.
10. Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging.
11. Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location).

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics

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)

Expected Enrollment

Outcomes

Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes
Potential of PET/CT imaging to change treatment of the N0 neck

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
Effect of other factors (e.g., tumor size, location, second 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
Cost-effectiveness and cost-benefit of using PET/CT imaging for staging of head and neck cancer vs current good clinical practices
Incidence of occult distant body metastasis discovered by whole body PET/CT imaging
Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results
Quality of life, particularly in patients whose management could have been altered by imaging results
Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction
Comparison of 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
Proportion of neck dissections that are extended based on local-reader PET/CT imaging findings shared with the surgeon before dissection
Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging
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.

Trial Contact Information

Trial Lead Organizations

American College of Radiology Imaging Network

Val Lowe, MD, Protocol chair		Ph: 507-284-4104

U.S.A.
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Brendan Stack, MD	Ph:  501-686-5140
California
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
Florida
	Safety Harbor
	Morton Plant Mease Cancer Care at Mease Countryside Hospital
		Yair Safriel, MD	Ph:  727-461-8885
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Clinical Trials Office - H. Lee Moffitt Cancer Center and Reseach Institute	Ph:  800-456-7121
			Email: canceranswers@moffitt.org
Kentucky
	Louisville
	Jewish Hospital Heart and Lung Institute
		Robert Falk, MD	Ph:  502-583-2731
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Farrokh Dehdashti, MD	Ph:  314-747-1624
North Carolina
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Carol Geer, MD	Ph:  336-716-4687
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Laurie Loevner, MD	Ph:  215-662-7273
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Charles Intenzo, MD	Ph:  215-955-8606
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Ph:  215-955-6084
China
	Beijing
	Peking Union Medical College Hospital
		Fang Li, MD	Ph:  86-10-6529-5505

Registry Information
Official Title		A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients
Trial Start Date		2010-04-01
Trial Completion Date		2011-07-01 (estimated)
Registered in ClinicalTrials.gov		NCT00983697
Date Submitted to PDQ		2009-09-10
Information Last Verified		2012-01-26
NCI Grant/Contract Number		CA80098

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