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

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Cancer
• Interventions: Device: 1-mm Resolution Clinical PET camera

• Registration Number: NCT04662554
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-14
• Last Update Posted: 2024-12-17
• Study Start: 2025-06
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Novel PET Camera	1-mm Resolution Clinical 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States