High-Resolution PET Imaging for Head and Neck Cancer

Overseen By Grace Yi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new type of PET scan that captures super-clear images of head and neck cancer (HNC). The aim is to evaluate the performance and image clarity of the new 1-mm Resolution Clinical PET camera in a real medical setting. The trial seeks individuals diagnosed with head and neck cancer who are scheduled for surgery and already have a PET/CT scan planned. Participants will undergo an additional scan with this new camera, without any extra radiation. As an unphased trial, this study provides a unique opportunity to advance imaging technology for cancer diagnosis.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this PET camera is safe for imaging head and neck cancer patients?

Research has shown that PET/CT scans are commonly used for head and neck cancer and are generally considered safe. Although specific safety data for the new high-resolution PET camera is not available, it provides more detailed images without increasing radiation exposure.

Standard PET/CT scans are usually well-tolerated, indicating that this new camera should also be safe. It does not use additional radioactive material, so the risk remains the same as a regular PET/CT scan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the High-Resolution PET Imaging for Head and Neck Cancer because it offers a clearer view of tumors than standard PET/CT scans. This new PET camera boasts a 1-mm resolution, enhancing the detail and precision of cancer imaging. Unlike traditional methods, which may miss subtle changes, this high-resolution imaging can better detect and monitor head and neck cancers without adding extra radioactivity. The potential to improve diagnostic accuracy and treatment planning is a game-changer in cancer care.

What evidence suggests that this PET camera is effective for imaging head and neck cancer?

Research has shown that the 1-mm Resolution Clinical PET camera, used by participants in this trial, provides exceptionally clear images, crucial for detecting head and neck cancer. Studies have found that this detail is particularly useful for identifying small, hard-to-find growths, common in this area due to its complex structure. Early results suggest that such clear imaging can enhance the accuracy and effectiveness of cancer treatment planning. This advanced imaging technology holds promise by capturing clearer pictures, aiding doctors in making better decisions. ^{1 3 4 6 7}

Who Is on the Research Team?

Eben Rosenthal, Ph.D

Principal Investigator

Stanford Universiy

Are You a Good Fit for This Trial?

This trial is for adults 19 years or older with a biopsy-confirmed diagnosis of head and neck cancer (HNC), who are scheduled for surgery and a PET/CT scan. It's not suitable for those with conditions that could affect their participation as judged by the study leader.

Inclusion Criteria

I am scheduled for surgery for head and neck cancer.

Scheduled to have a PET/CT study on a conventional PET/CT system

My diagnosis of head and neck cancer was confirmed by a biopsy.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo a PET scan with the novel 1 mm resolution PET camera

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 1-mm Resolution Clinical PET camera

Trial Overview The trial is testing a new PET camera system with 1-mm resolution to evaluate its image quality in diagnosing HNC, compared to conventional PET/CT systems, within a clinical setting.

How Is the Trial Designed?

Group I: Novel PET Camera Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Emerson Collective

Collaborator

Trials

3

Recruited

700+

Goldman Sachs Foundation

Collaborator

Trials

1

Recruited

10+

Wallace H. Coulter Foundation

Collaborator

Trials

14

Recruited

1,300+

Published Research Related to This Trial

FDG-PET demonstrated a high sensitivity of 96% for detecting lymph node metastases in patients with primary head and neck cancer, outperforming CT and ultrasonography with fine-needle aspiration cytology (US/FNAC).

The use of FDG-PET also revealed second primary tumors in 17% of patients, highlighting its importance in comprehensive cancer assessment and suggesting it should be routinely used in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative evaluation of patients with primary head and neck cancer using dual-head 18fluorodeoxyglucose positron emission tomography. Stokkel, MP., ten Broek, FW., Hordijk, GJ., et al.[2019]

In a study involving 12 patients with head and neck squamous cell carcinoma, the radiotracer [18F]FDG was found to be more effective than [68Ga]Ga-PentixaFor in detecting disease, identifying 100% of primary tumors compared to 83% for [68Ga]Ga-PentixaFor.

Quantitative analysis showed that [18F]FDG provided significantly better image contrast, with higher target-to-background ratios for all lesions, suggesting it may be the preferred choice for diagnostic imaging in this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic efficacy of C-X-C motif chemokine receptor 4-directed PET/CT in newly diagnosed head and neck squamous cell carcinoma - a head-to-head comparison with [18F]FDG. Zhi, Y., Werner, RA., Schirbel, A., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-2-2022-f4858

High-Resolution PET Imaging for Head and Neck Cancer The 1-mm Resolution Clinical PET camera offers a unique advantage by providing high-resolution imaging, which can improve the accuracy of detecting and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7337125/

Design study of a dedicated head and neck cancer PET ... However, lesions in this region can be challenging to diagnose due to the thin, soft tissues within the neck, which require a high-resolution imaging system.

3. mdpi.com mdpi.com/2076-3417/15/9/5207

Ultra-High Spatial Resolution Clinical Positron Emission ... This paper emphasizes progress toward achieving ≤2 mm isotropic spatial resolution in clinical PET systems, and in particular focuses on describing a 1 mm3 ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/55/supplement_1/2155

High resolution PET/CT imaging for head and neck radiation ... Conclusions The results from this initial investigation demonstrate the potential of a high resolution PET-CT system for planning of radiotherapy of head and ...

5. researchgate.net researchgate.net/publication/391526258_Ultra-High_Spatial_Resolution_Clinical_Positron_Emission_Tomography_PET_Systems

Ultra-High Spatial Resolution Clinical Positron Emission ... We are developing a 1-mm 3 resolution, high-sensitivity positron emission tomography (PET) system for loco-regional cancer imaging. The ...

6. smartpatients.com smartpatients.com/trials/NCT04662554

Study of a 1-Millimeter Resolution Clinical Positron ... The purpose of this study is to gain initial experience imaging HNC patient using a new PET camera, a 1mm spacial resolution.

7. auntminnie.com auntminnie.com/scott-williams/nuclear-medicine/pet/article/15561713/pet-imaging-general-topics

PET Imaging General Topics The only way for clinical PET to use smaller elements and improve resolution is to improve photon sensitivity [91]. This can be accomplished by ...