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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Metastatic Malignant Neoplasm in the Spine; Metastatic Head and Neck Squamous Cell Carcinoma

Treatments: Procedure: Positron Emission Tomography; Other: Fludeoxyglucose F-18; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03575949

NCI-2018-02640 (Registry Identifier)

2017-0826 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVE:

I. 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)
• Pregnant women

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Diagnostic (FDG PET/CT)

Experimental group

Description:

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.

Treatment:

Procedure: Computed Tomography

Other: Fludeoxyglucose F-18

Procedure: Positron Emission Tomography