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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, Diagnostic, Health services research18 and overACRIN 6685
NCI-2011-01972, CA80098, CDR0000654703, NCT00983697

Trial Description

Summary

This phase II trial is studying fludeoxyglucose F 18-positron emission tomography (PET)/computed tomography (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. Diagnostic procedures, such as fludeoxyglucose F 18 (FDG)-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.

Further Study Information

PRIMARY OBJECTIVES:

I. Determine the negative predictive value (NPV) of PET/CT for staging the N0 neck based upon pathologic sampling of the neck lymph nodes.

II. Determine PET/CT’s potential to change treatment of the N0 neck.

SECONDARY OBJECTIVES:

I. Estimate the 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.

II. 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.

III. Analyze cost-effectiveness of using PET/CT for staging of head and neck cancer versus current good clinical practices.

IV. Evaluate the incidence of occult distant body metastasis discovered by whole body PET/CT;

V. Correlate PET/CT findings to CT/MRI and biomarker results.

VI. Evaluate quality of life (QoL), particularly in participants whose patient management could have been altered by imaging results.

VII. Evaluate the PET/CT and biomarker data for complementary contributions to metastatic disease prediction.

VIII. Compare baseline PET/CT and biomarker data to 2-year follow up as an adjunct assessment of their prediction of recurrence, disease-free survival, and overall survival.

IX. Determine the proportion of neck dissections that are extended—additional levels clinicians intend to dissect beyond the initial surgery plan—based on local-reader PET/CT findings shared with the surgeon prior to dissection.

X. Estimate the optimum cutoff value of standardized uptake values (SUV) for diagnostic accuracy of PET/CT test.

XI. Evaluate the impact of PET/CT on the N0 neck across different tumor subsites (defined by anatomic location).

OUTLINE:

Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients undergo unilateral or bilateral neck dissection.

After completion of study treatment, patients are followed up periodically for up to 2 years.

Eligibility Criteria

Inclusion Criteria:

Participant with histologic confirmation of newly diagnosed squamous cell carcinoma (SCC) of the head and neck

Participant with unilateral or bilateral neck dissection planned for care; an 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

Participant willing to provide a written informed consent

Participant in whom it may be considered a viable clinical option to perform neck dissection when primary cancers are at high risk for neck metastasis (see definition above);

These will include: 1) oral cavity cancer; 2) oropharynx cancer, including base of tongue and tonsil cancers; 3) larynx cancer; or 4) supraglottic cancer

Participant with at least one neck that is clinically N0 as defined by clinical exam (physical exam with CT and/or MRI as the gold standard of the N0 neck); stages T2, T3, or T4. N0–N3, excluding N2c for bilateral disease based on criteria from the American Joint Commission on Cancer (available through the National Comprehensive Cancer Network www.nccn.org/professionals/physician_gls/PDF/head-and-neck.pdf; web site registration required)

Participant with confirmed head and neck SCC:

CT and/or MR imaging has been completed within six (6) weeks prior to enrollment, even if the SCC diagnosis has been made via other methods, and will be submitted to American College of Radiology Imaging Network (ACRIN);

Simultaneous diagnostic CT with PET will not be excluded, but in such cases PET cannot be used as part of the criteria to define the N0 neck as required for entrance to the trial;

If sites received CT and/or MR images from institutions other than their own, ACRIN recommends a re-read by a local neuroradiologist to ensure compliance with protocol eligibility requirements

Exclusion Criteria:

Patient not a candidate for surgery (neck dissection) because of an underlying medical condition

Patient who is pregnant and/or breastfeeding

Patient with sinonasal carcinoma

Patient with tumors in the head and neck that are not SCC

Patient with salivary gland malignancies

Patient with thyroid cancers

Patient with advanced skin cancers

Patient with nasopharyngeal carcinoma

Patient with poorly controlled diabetes (defined as fasting glucose level >= 200 mg/dL; optimally participants will have glucose < 150 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications

Patient who weighs more than the weight limit for the PET table

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

American College of Radiology Imaging Network

  • National Cancer Institute
Val J. Lowe, Principal Investigator

Trial Sites

U.S.A.

Arkansas
Little Rock

University of Arkansas for Medical Sciences

Brendan Curran Stack
Ph: 501-686-8274

Brendan Curran Stack
Principal Investigator

California
Duarte

City of Hope Comprehensive Cancer Center

Val J. Lowe

Val J. Lowe
Principal Investigator

Los Angeles

USC / Norris Comprehensive Cancer Center

Val J. Lowe

Val J. Lowe
Principal Investigator

Florida
Dunedin

Morton Plant Mease

Val J. Lowe

Val J. Lowe
Principal Investigator

Jacksonville

University of Florida Health Science Center

Barry M. McCook
Ph: 888-254-7581

Barry M. McCook
Principal Investigator

Tampa

Moffitt Cancer Center

Val J. Lowe

Val J. Lowe
Principal Investigator

Illinois
Springfield

Southern Illinois University School of Medicine

Val J. Lowe

Val J. Lowe
Principal Investigator

Louisiana
Shreveport

Biomedical Research Foundation of Northwest Louisiana PET Imaging Center

Amol Madan Takalkar
Ph: 888-685-1152

Amol Madan Takalkar
Principal Investigator

Maryland
Baltimore

Johns Hopkins University/Sidney Kimmel Cancer Center

Rathan Subramaniam
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Rathan Subramaniam
Principal Investigator

Minnesota
Rochester

Mayo Clinic

Val J. Lowe
Ph: 507-538-7623

Val J. Lowe
Principal Investigator

Missouri
Saint Louis

Washington University School of Medicine

Brian Nussenbaum
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Brian Nussenbaum
Principal Investigator

Springfield

Mercy Hospital Springfield

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

New York
New York

Weill Medical College of Cornell University

Val J. Lowe

Val J. Lowe
Principal Investigator

North Carolina
Winston-Salem

Wake Forest University Health Sciences

Val J. Lowe

Val J. Lowe
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Charles D. Arnold
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Charles D. Arnold
Principal Investigator

Pennsylvania
Philadelphia

Fox Chase Cancer Center

Jian Qin (Michael) Yu
Ph: 215-728-4790

Jian Qin (Michael) Yu
Principal Investigator

Thomas Jefferson University Hospital

Charles M. Intenzo
Ph: 215-955-6084

Charles M. Intenzo
Principal Investigator

Val J. Lowe

Val J. Lowe
Principal Investigator

Washington
Seattle

University of Washington Medical Center

Yoshimi Anzai
Ph: 206-616-8289

Yoshimi Anzai
Principal Investigator

China

Beijing

Peking Union Medical College Hospital

Val J. Lowe

Val J. Lowe
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00983697

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.