Head and Neck CancerNCT04662554
Study of a 1-Millimeter Resolution Clinical Positron Emission Tomography (PET) System in Head and Neck Cancer Imaging
A study testing 1-mm Resolution Clinical PET camera in people with Head and Neck Cancer, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- 1-mm Resolution Clinical PET camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Stanford, California, 94304
Grace Yi, 650-723-4467, gracesyi@stanford.edu
Eben Rosenthal, Ph.D
About this study
Official title: Pilot Study of a 1-Millimeter Resolution Clinical PET System in Head and Neck Cancer Imaging
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- 1-mm Resolution Clinical PET camera
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-mm Resolution Clinical PET cameraDevice
1-Millimeter Resolution Clinical PET System in Head and Neck Cancer (HNC) Imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 1-mm Resolution Clinical PET camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Goldman Sachs Foundation, Wallace H. Coulter Foundation, Emerson Collective
- Responsible party
- Sponsor
- Investigators
- Eben Rosenthal, Ph.D, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662554
- Sponsor's protocol ID
- IRB-55884
- Other IDs
- ENT0080
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2020
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a 1-Millimeter Resolution Clinical PET System in Head and Neck Cancer Imaging
- ClinicalTrials.gov ID
- NCT04662554
- Acronym / sponsor ID
- IRB-55884
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Goldman Sachs Foundation, Wallace H. Coulter Foundation, Emerson Collective
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel PET Camera | Experimental | Device: 1-mm Resolution Clinical PET cameraPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-mm Resolution Clinical PET camera1-Millimeter Resolution Clinical PET System in Head and Neck Cancer (HNC) Imaging | Device | Novel PET Camera |
Primary outcome
Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device.
Time frame: 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.
1 secondary outcome
Measure image quality of the 1 mm resolution PET imaging device
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eben Rosenthal, Ph.D principal investigator
Stanford Universiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-mm Resolution Clinical PET camera in people with Head and Neck Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grace Yi (650-242-2666, gracesyi@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.