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

NCT ID: NCT03575949

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2024-05-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo FDG PET/CT

Fludeoxyglucose F-18

Intervention Type OTHER

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo FDG PET/CT

Interventions

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Computed Tomography

Undergo FDG PET/CT

Intervention Type PROCEDURE

Fludeoxyglucose F-18

Given IV

Intervention Type OTHER

Positron Emission Tomography

Undergo FDG PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT scan Computerized Axial Tomography computerized tomography CT CT scan tomography 18FDG FDG Fludeoxyglucose (18F) fludeoxyglucose F 18 Fludeoxyglucose F18 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose Fluorodeoxyglucose F18 Medical Imaging, Positron Emission Tomography PET PET scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason M Johnson

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2018-02640

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-0826

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0826

Identifier Type: -

Identifier Source: org_study_id

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