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Standard and Delayed FDG PET/CT After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03575949
Collaborator
National Cancer Institute (NCI) (NIH)
50
Enrollment
1
Location
1
Arm
54.5
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial studies how well standard and delayed fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) given after standard radiation and chemotherapy works in assessing patients with head and neck squamous cell cancer that has spread to other places in the body. Diagnostic procedures, such as PET/CT, use radioactive material, such as fludeoxyglucose F-18, to find and diagnose head and neck tumors and may help to find out how far the disease has spread.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computed Tomography
  • Other: Fludeoxyglucose F-18
  • Procedure: Positron Emission Tomography
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. To assess the optimal imaging time using FDG positron emission tomography (PET) with comparison between a standard of care 1-hour scan (early) and the research scan of 3-hours scan (delayed) post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background [L/B] ratio) in patients with head and neck primary squamous cell carcinoma following chemoradiation treatment.
OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute and undergo PET/CT at 70 and 180 minutes after injection at 12-14 weeks following standard chemoradiation (CRT) completion.

After completion of study, patients are followed up at 30 days and then periodically for up to 6 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Dual-Time Point (DTP) FDG PET CT for the Post-Treatment Assessment of Head and Neck Tumors Following Definitive Chemoradiation Therapy
Actual Study Start Date :
Jun 15, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (FDG PET/CT)

Patients receive fludeoxyglucose F-18 IV over 1 minute and undergo PET/CT at 70 and 180 minutes after injection at 12-14 weeks following standard CRT completion.

Procedure: Computed Tomography
Undergo FDG PET/CT
Other Names:
  • CAT
  • CAT scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT scan
  • tomography

    • Other: Fludeoxyglucose F-18
    Given IV
    Other Names:
  • 18FDG
  • FDG
  • Fludeoxyglucose (18F)
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

    • Procedure: Positron Emission Tomography
    Undergo FDG PET/CT
    Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Optimal imaging time [Up to 6 months]

      Determined by fludeoxyglucose F-18 (FDG) positron emission tomography. The optimal time point is defined as the time point that meets the following requirements: 1) it has the largest average lesion/background (L/B) ratio, and 2) if the delayed time point is greater, it must be significantly different from the initial time point at the 0.025 significance level. The acquired PET data will be reconstructed using iterative techniques with resolution recovery. All delayed time points will then be registered using rigid techniques to the standard of care initial PET/CT image. Volumes of interest around the largest nodal metastasis will be drawn and the standard uptake value (SUV) max will be calculated. A corresponding region for largest nodal metastasis will be drawn on the contralateral sternocleidomastoid muscle respective to each lesion to determine L/B ratio, where L is the lesion SUV max and B is the corresponding background SUV max.

    2. Differences in L/B ratio [Up to 6 months]

      Differences in L/B ratio between the initial and delayed time point will be tested via paired t-test after appropriate transformation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult with computed tomography (CT) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET) findings of cervical nodal metastasis from a head and neck primary squamous cell carcinoma treated with definitive chemoradiation
    Exclusion Criteria:

    • Children

    • No evidence of cervical nodal metastasis

    • Active infection of the head and neck

    • Known allergy to FDG, iodine or gadolinium-based contrast agents

    • Blood glucose (> 250 mg/dl)

    • Severe renal dysfunction (glomerular filtrate rate [within 30 days] less than 30)

    • Pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jason M Johnson, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03575949
    Other Study ID Numbers:
    • 2017-0826
    • NCI-2018-02640
    • 2017-0826
    • P30CA016672
    First Posted:
    Jul 3, 2018
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Squamous Cell Carcinoma of Head and Neck
    Neoplasms
    Deoxyglucose
    Fluorodeoxyglucose F18

    Study Results

    No Results Posted as of May 26, 2022