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

NCT ID: NCT04662554

Last Updated: 2025-07-15

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-06-30

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):

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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Novel PET Camera

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.

Group Type EXPERIMENTAL

1-mm Resolution Clinical PET camera

Intervention Type DEVICE

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

Interventions

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1-mm Resolution Clinical PET camera

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goldman Sachs Foundation

UNKNOWN

Sponsor Role collaborator

Wallace H. Coulter Foundation

OTHER

Sponsor Role collaborator

Emerson Collective

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eben Rosenthal, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Stanford Universiy

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Central Contacts

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Grace Yi

Role: CONTACT

650-242-2666

Facility Contacts

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Grace Yi

Role: primary

650-723-4467

Other Identifiers

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ENT0080

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-55884

Identifier Type: -

Identifier Source: org_study_id

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