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

Stanford University

Status: Begins enrollment in 3 months

Conditions: Head and Neck Cancer

Treatments: Device: 1-mm Resolution Clinical PET camera

Study type: Interventional

Funder types: Other

Identifiers

NCT04662554

ENT0080 (Other Identifier)

IRB-55884

Details and patient eligibility

About

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.

Full description

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):

1. Determine the radioactive dose and scan time required for this novel 1 millimeter (mm) resolution clinical PET camera.
2. 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Biopsy-confirmed diagnosis of HNC
2. Patient scheduled to undergo surgery for HNC
3. Scheduled to have a PET/CT study on a conventional PET/CT system
4. 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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Novel PET Camera

Experimental group

Description:

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.

Treatment:

Device: 1-mm Resolution Clinical PET camera