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NCT04662554 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04662554
Other study ID # IRB-55884
Secondary ID ENT0080
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date June 2025

Study information
Verified date March 2024
Source Stanford University
Contact Grace Yi
Phone 650-242-2666
Email gracesyi@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• 1-mm Resolution Clinical PET camera
1-Millimeter Resolution Clinical PET System in Head and Neck Cancer (HNC) Imaging

Locations
Country Name City State
United States Stanford University Stanford California

Sponsors (4)
Lead Sponsor Collaborator
Stanford University Emerson Collective, Goldman Sachs Foundation, Wallace H. Coulter Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device. 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. Day 1
Secondary Measure image quality of the 1 mm resolution PET imaging device 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. Day 1
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