FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer (ACRIN 6685)

This study is currently recruiting participants.
Verified August 2013 by American College of Radiology Imaging Network
Sponsor:
Collaborator:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00983697
First received: September 23, 2009
Last updated: August 19, 2013
Last verified: August 2013

September 23, 2009
August 19, 2013
April 2010
September 2014   (final data collection date for primary outcome measure)
  • Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Potential of PET/CT imaging to change treatment of the N0 neck [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes [ Designated as safety issue: No ]
  • Potential of PET/CT imaging to change treatment of the N0 neck [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00983697 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • 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 subs ... [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Cost-effectiveness and cost-benefit of using PET/CT imaging for staging of head and neck cancer vs current good clinical practices [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Incidence of occult distant body metastasis discovered by whole body PET/CT imaging [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Quality of life, particularly in patients whose management could have been altered by imaging results [ Time Frame: Two Years ] [ Designated as safety issue: No ]
  • Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Two Years ] [ Designated as safety issue: No ]
  • Proportion of neck dissections that are extended based on local-reader PET/CT imaging findings shared with the surgeon before dissection [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location) [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Effect of other factors (e.g., tumor size, location, 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 [ Designated as safety issue: No ]
  • Cost-effectiveness and cost-benefit of using PET/CT imaging for staging of head and neck cancer vs current good clinical practices [ Designated as safety issue: No ]
  • Incidence of occult distant body metastasis discovered by whole body PET/CT imaging [ Designated as safety issue: No ]
  • Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results [ Designated as safety issue: No ]
  • Quality of life, particularly in patients whose management could have been altered by imaging results [ Designated as safety issue: No ]
  • Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Proportion of neck dissections that are extended based on local-reader PET/CT imaging findings shared with the surgeon prior to dissection [ Designated as safety issue: No ]
  • Optimum cutoff value of SUV for diagnostic accuracy of PET/CT imaging [ Designated as safety issue: No ]
  • Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location) [ Designated as safety issue: No ]
Not Provided
Not Provided
 
FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Head and Neck Cancer
  • Other: laboratory biomarker analysis
  • Procedure: quality-of-life assessment
  • Procedure: therapeutic conventional surgery
  • Radiation: fludeoxyglucose F 18
Experimental: FDG PET/CT
Surgical planning for the N0 neck is documented prior to and immediately after review of the FDG-PET/CT scan completed per protocol.
Interventions:
  • Other: laboratory biomarker analysis
  • Procedure: quality-of-life assessment
  • Procedure: therapeutic conventional surgery
  • Radiation: fludeoxyglucose F 18
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
292
Not Provided
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States,   China
 
NCT00983697
CDR0000654703, ACRIN-6685, CA80098
Yes
American College of Radiology Imaging Network
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Val J. Lowe, MD Mayo Clinic
American College of Radiology Imaging Network
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP