Study of a 1-Millimeter Resolution Clinical Positron Emission Tomography (PET) System in Head and Neck Cancer Imaging

Study Overview
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Brief Summary
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The purpose of this study is to gain initial experience imaging HNC patient using a new PET camera, a 1mm spacial resolution. The goal is to understand image quality of the system and to see how it works in a clinical environment.

Detailed Description
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PRIMARY OBJECTIVE(S): Gain initial experience imaging head/neck cancer patients using a novel PET camera comprising two opposing panels with 1 millimeter spatial resolution. SECONDARY OBJECTIVE(S): Determine the radioactive dose and scan time required for this novel 1 millimeter (mm) resolution clinical PET camera. Images obtained with the 1 mm resolution PET camera will be compared to conventional PET imaging (which will serve as gold standard) for image quality and lesion/node visualization.

Official Title
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Pilot Study of a 1-Millimeter Resolution Clinical PET System in Head and Neck Cancer Imaging

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Device: 1-mm Resolution Clinical PET camera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-confirmed diagnosis of HNC Patient scheduled to undergo surgery for HNC Scheduled to have a PET/CT study on a conventional PET/CT system Age greater than or equal to 19 years of age. Exclusion Criteria: 1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel PET Camera<br>Patients already undergoing a PET/CT scan for HNC will afterwards undergo a PET scan with the proposed device, thus no additional radioactivity is needed as part of this study. | Device: 1-mm Resolution Clinical PET camera<br>* 1-Millimeter Resolution Clinical PET System in Head and Neck Cancer (HNC) Imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device. | PET images of HNC patients with the 1 mm resolution PET imaging device will be qualitatively accessed whether the camera can visualize the primary lesion, including heterogeneity and lymph nodes will be assessed. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure image quality of the 1 mm resolution PET imaging device | Image quality of the 1 mm resolution PET imaging device (scale 1-5) with 5 being highest 'image quality' will be assessed to understand radioactive dose and scan time required for a given desired image quality. | Day 1 |