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

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04662554

Collaborator

Goldman Sachs Foundation (Other), Wallace H. Coulter Foundation (Other), Emerson Collective (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Device: 1-mm Resolution Clinical PET camera	N/A

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):

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 1-mm Resolution Clinical PET camera 1-Millimeter Resolution Clinical PET System in Head and Neck Cancer (HNC) Imaging

Arm

Intervention/Treatment

Experimental: 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.

Device: 1-mm Resolution Clinical PET camera

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94304

Sponsors and Collaborators

Stanford University
Goldman Sachs Foundation
Wallace H. Coulter Foundation
Emerson Collective

Investigators

Principal Investigator: Eben Rosenthal, Ph.D, Stanford Universiy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT04662554

Other Study ID Numbers:

IRB-55884
ENT0080

First Posted:

Dec 10, 2020

Last Update Posted:

Jun 14, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Jun 14, 2022