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NCT Number: NCT04662554

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94304, United States

Location contact

Eben Rosenthal, Ph.D

PRINCIPAL_INVESTIGATOR

Grace Yi

CONTACT

[email protected]

650-723-4467

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.

Treatment and study plan

1-mm Resolution Clinical PET camera

Device

1-Millimeter Resolution Clinical PET System in Head and Neck Cancer (HNC) Imaging

Primary outcomes

  1. Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device.

    Time frame: Day 1

    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.

Secondary outcomes

  1. Measure image quality of the 1 mm resolution PET imaging device

    Time frame: Day 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Yi

CONTACT

[email protected]

650-242-2666

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Emerson Collective
  • Goldman Sachs Foundation
  • Wallace H. Coulter Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2020
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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