Study of a 1-Millimeter Resolution Clinical Positron Emission Tomography (PET) System in Head and Neck Cancer Imaging
Primary Purpose
Head and Neck Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1-mm Resolution Clinical PET camera
Sponsored by
About this trial
This is an interventional device feasibility trial for Head and Neck Cancer
Eligibility Criteria
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:
1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Novel PET Camera
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04662554
First Posted
November 6, 2020
Last Updated
May 23, 2023
Sponsor
Stanford University
Collaborators
Goldman Sachs Foundation, Wallace H. Coulter Foundation, Emerson Collective
1. Study Identification
Unique Protocol Identification Number
NCT04662554
Brief Title
Study of a 1-Millimeter Resolution Clinical Positron Emission Tomography (PET) System in Head and Neck Cancer Imaging
Official Title
Pilot Study of a 1-Millimeter Resolution Clinical PET System in Head and Neck Cancer Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
Goldman Sachs Foundation, Wallace H. Coulter Foundation, Emerson Collective
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Novel PET Camera
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
1-mm Resolution Clinical PET camera
Intervention Description
1-Millimeter Resolution Clinical PET System in Head and Neck Cancer (HNC) Imaging
Primary Outcome Measure Information:
Title
Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device.
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Measure image quality of the 1 mm resolution PET imaging device
Description
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.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Yi
Phone
650-242-2666
Email
gracesyi@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eben Rosenthal, Ph.D
Organizational Affiliation
Stanford Universiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Yi
Phone
650-723-4467
Email
gracesyi@stanford.edu
First Name & Middle Initial & Last Name & Degree
Eben Rosenthal, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of a 1-Millimeter Resolution Clinical Positron Emission Tomography (PET) System in Head and Neck Cancer Imaging
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