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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04662554

Enrollment

Registered

2020-12-10

Start date

2026-09-01

Completion date

2027-06-01

Last updated

2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Brief summary

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

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.

Interventions

DEVICE1-mm Resolution Clinical PET camera

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

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device.	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

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

Countries

United States

Contacts

CONTACTGrace Yi

gracesyi@stanford.edu650-242-2666

PRINCIPAL_INVESTIGATOREben Rosenthal, Ph.D

Stanford Universiy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026