NCT04662554

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
12mo left

Started Jun 2026

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
5.5 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

November 6, 2020

Last Update Submit

July 12, 2025

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Measure image quality of the 1 mm resolution PET imaging device

    Day 1

Study Arms (1)

Novel PET Camera

EXPERIMENTAL

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

Interventions

1-mm Resolution Clinical PET cameraDEVICE

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

Novel PET Camera

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Eben Rosenthal, Ph.D

    Stanford Universiy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Yi

CONTACT

650-242-2666gracesyi@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

December 10, 2020

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)