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FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer (ACRIN6685)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00983697
First Posted: September 24, 2009
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
American College of Radiology Imaging Network
September 23, 2009
September 24, 2009
March 20, 2017
April 2010
December 2018   (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 ]
  • Potential of PET/CT imaging to change treatment of the N0 neck [ Time Frame: Within Two Weeks Before Surgery ]
  • 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
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 ]
  • 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 ]
  • 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 ]
  • Incidence of occult distant body metastasis discovered by whole body PET/CT imaging [ Time Frame: Within Two Weeks Before Surgery ]
  • Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results [ Time Frame: Within Two Weeks Before Surgery ]
  • Quality of life, particularly in patients whose management could have been altered by imaging results [ Time Frame: Two Years ]
  • Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction [ Time Frame: Within Two Weeks Before Surgery ]
  • 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 ]
  • 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 ]
  • Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging [ Time Frame: Within Two Weeks Before Surgery ]
  • Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location) [ Time Frame: Within Two Weeks Before Surgery ]
  • 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, 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 prior to dissection
  • Optimum cutoff value of SUV for diagnostic accuracy of PET/CT imaging
  • Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location)
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
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Head and Neck Cancer
  • Procedure: therapeutic conventional surgery
  • Radiation: fludeoxyglucose F 18
Experimental: FDG PET/CT
Planning for Therapeutic conventional surgery of the N0 neck is documented prior to and immediately after review of the fludeoxyglucose F 18 (FDG)-PET/CT scan completed per protocol.
Interventions:
  • 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.
 
Active, not recruiting
292
December 2019
December 2018   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   United States
 
 
NCT00983697
CDR0000654703
ACRIN-6685 ( Other Identifier: CIP ID )
U01CA080098 ( U.S. NIH Grant/Contract )
U01CA079778 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description:

See ACRIN data sharing policy:

https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

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
March 2017

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