What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, such as radiation therapy (RT) and chemoradiation, are associated with several side effects. Short-term side effects include mucositis, which can be severe and confluent, leading to difficulties in swallowing and the need for tube feeding. Long-term side effects can include ulceration, soft tissue necrosis, fibrosis, dysphagia, and osteoradionecrosis. The severity of these side effects often correlates with the dose and duration of the treatment. Additionally, chemoradiation can lead to increased immunosuppression and gastrointestinal distress.

What prior FDA approvals exist?

FDA-approved treatments for head and neck cancers include cetuximab, a monoclonal antibody targeting the EGFR, which has been used in combination with chemotherapy to improve overall survival. Pembrolizumab and nivolumab, both immune checkpoint inhibitors targeting PD-1, have also been approved for recurrent or metastatic head and neck squamous cell carcinoma. These treatments are relevant to high-resolution PET imaging studies as they can help in assessing the metabolic response and progression of the disease.

What other types of research exist?

Promising alternatives to the new high-resolution PET camera for head and neck cancer patients include hybrid PET/CT and PET/MRI systems. These modalities offer combined functional and structural imaging, improving diagnostic accuracy and treatment planning. Additionally, advancements in image processing software, reconstruction algorithms, and the integration of artificial intelligence are expected to further enhance imaging capabilities in 2024.

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Imaging Device

High-Resolution PET Imaging for Head and Neck Cancer

N/A

Waitlist Available

Led By Eben Rosenthal, Ph.D

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient scheduled to undergo surgery for HNC

Biopsy-confirmed diagnosis of HNC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

Study Summary

This trial is to test a new PET camera's imaging quality on cancer patients and how it works in a clinical setting.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves imaging rather than medication or invasive treatment, there are no direct side effects from the intervention itself. However, standard risks associated with undergoing PET/CT scans apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for surgery for head and neck cancer.

Select...

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

Select...

I am 19 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device.

Secondary outcome measures

Measure image quality of the 1 mm resolution PET imaging device

Trial Design

1Treatment groups

Experimental Treatment

Group I: Novel PET CameraExperimental Treatment1 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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Head and Neck Cancers include radiation therapy, chemotherapy, and immunotherapy. Radiation therapy works by damaging the DNA of cancer cells, which inhibits their ability to replicate and leads to cell death. Chemotherapy uses cytotoxic drugs to target rapidly dividing cells, including cancer cells, disrupting their growth and division. Immunotherapy, such as the use of pembrolizumab, enhances the body's immune system to recognize and attack cancer cells. High-resolution PET imaging is crucial for these patients as it allows for precise detection and monitoring of tumors, enabling tailored treatment plans that can improve outcomes and minimize side effects.

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