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

10 Participants Needed

Trial Summary

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 data supports the effectiveness of the 1-mm Resolution Clinical PET camera treatment for head and neck cancer?

Research shows that PET imaging is highly effective in detecting and staging head and neck cancer, improving the planning of treatments like radiotherapy, and monitoring the response to treatments. This suggests that a high-resolution PET camera could enhance these benefits by providing even more detailed images, potentially leading to better treatment outcomes. ^{1 2 3 4 5}

Is high-resolution PET imaging safe for humans?

The research articles do not provide specific safety data for high-resolution PET imaging, but PET/CT imaging is widely used in clinical practice for head and neck cancer, suggesting it is generally considered safe when used according to established guidelines. ^{2 6 7 8 9}

How does the 1-mm Resolution Clinical PET camera treatment differ from other treatments 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 monitoring head and neck cancer compared to standard imaging techniques. This allows for better planning of radiation therapy and more precise evaluation of tumor response to treatment. ^{2 3 5 10 11}

What is the purpose of this trial?

This trial is testing a new PET scan machine that takes very detailed pictures to help doctors see head and neck cancers more clearly.

Research Team

Eben Rosenthal, Ph.D

Principal Investigator

Stanford Universiy

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Positron-emission tomography for head and neck cancer. [2015]

2. Ireland pubmed.ncbi.nlm.nih.gov

¹⁸F-FDG-PET imaging in radiotherapy tumor volume delineation in treatment of head and neck cancer. [2019]

3. Spain pubmed.ncbi.nlm.nih.gov

[Positron emission tomography (PET) imaging in head and neck cancer]. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[Current state of PET in head and neck tumours: impact on the planning of radiotherapy treatment]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Positron-emission tomography for surveillance of head and neck cancer. [2016]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Preoperative evaluation of patients with primary head and neck cancer using dual-head 18fluorodeoxyglucose positron emission tomography. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The potential role of non-FDG-PET in the management of head and neck cancer. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Quality Assessment in FDG-PET/CT Imaging of Head-and-Neck Cancer: One Home Run Is Better Than Two Doubles. [2020]

10. Spain pubmed.ncbi.nlm.nih.gov

The diagnostic possibilities of positron emission tomography (PET): applications in oral and maxillofacial buccal oncology. [2016]

11. Germany pubmed.ncbi.nlm.nih.gov

Combined image interpretation of computed tomography and hybrid PET in head and neck cancer. [2016]