What is the mechanism of action of this treatment?

The most common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) often involve targeting the epidermal growth factor receptor (EGFR). Monoclonal antibodies like cetuximab and panitumumab bind to EGFR on cancer cells, blocking its activation and the downstream signaling pathways that promote tumor growth and survival. This inhibition can reduce tumor proliferation and enhance the effectiveness of other treatments such as radiation and chemotherapy. For HNSCC patients, targeting EGFR is significant because it directly interferes with the cancer's growth mechanisms, potentially improving treatment outcomes and offering a more personalized therapeutic approach.

What side effects are associated with this type of intervention?

Common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) involving EGFR-targeting agents like panitumumab and cetuximab often result in side effects such as skin rash, diarrhea, anorexia, and hypomagnesemia. Severe adverse events can include severe skin reactions, sepsis, and infusion-related reactions. When combined with chemotherapy, these treatments can also increase the risk of nausea, vomiting, and severe hypomagnesemia.

What prior FDA approvals exist?

Cetuximab, an anti-EGFR monoclonal antibody, is the primary FDA-approved targeted therapy for the treatment of Head and Neck Squamous Cell Carcinoma (HNSCC). It is approved for use in combination with radiotherapy for locally advanced tumors and with chemotherapy for recurrent or metastatic disease. Panitumumab, another anti-EGFR monoclonal antibody, has been studied but is not established for HNSCC treatment due to limited efficacy in improving overall survival compared to cetuximab.

What other types of research exist?

Promising alternatives to Zirconium-89 (89Zr) panitumumab-PET/MRI for imaging in Head and Neck Squamous Cell Carcinoma (HNSCC) include: 1. 18F-Fluorodeoxyglucose (18F-FDG) PET/MRI, which is already a standard of care and widely used for its effectiveness in identifying tumor size and location. 2. 64Cu-DOTA-panitumumab, which has shown high radiochemical purity and high affinity EGFR binding, making it a potential alternative for precise imaging. 3. 68Ga-PSMA PET/CT, which has been effective in other cancers and could be explored for HNSCC due to its high sensitivity and specificity in detecting cancerous lesions.

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[89Zr]Panitumumab Imaging for Head and Neck Cancer

Phase < 1

Recruiting

Led By Suzanne Lapi, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Planned standard of care surgery with curative intent for squamous cell carcinoma

Age > 18 years

Must not have

Previous HNSCC resection

Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-9 days prior to surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new imaging method using a special radioactive substance to better locate and measure head and neck tumors in patients. It aims to provide clearer images than the current standard method. The study involves injecting a small amount of a drug to help the radioactive substance attach to the tumor cells, making them more visible on scans.

Who is the study for?

This trial is for adults over 18 with newly diagnosed head and neck squamous cell carcinoma, scheduled for surgery. Participants must have normal organ function tests, no history of severe heart or liver conditions within the past 6 months, not be pregnant or breastfeeding, and cannot exceed a weight limit due to scanner size.

What is being tested?

[89Zr]Panitumumab PET/MRI imaging is being tested against standard [18F-FDG] PET/MRI to see if it's better at finding the exact size and location of tumors in patients with head and neck cancer. This study will not affect treatment plans as it's only for imaging purposes.

What are the potential side effects?

Since this trial focuses on imaging rather than treatment, side effects are minimal but may include allergic reactions to panitumumab tracer components or issues related to MRI procedures like discomfort from lying still.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for surgery to remove my squamous cell carcinoma.

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I am older than 18 years.

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I am scheduled for surgery for my newly diagnosed head or neck cancer.

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My cancer has not spread to my lymph nodes according to tests.

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My blood, kidney, and liver tests are within normal ranges.

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I have been diagnosed with squamous cell carcinoma in the head or neck.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had surgery to remove head or neck cancer.

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I have had interstitial pneumonitis or pulmonary fibrosis.

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I am taking medication for heart rhythm problems.

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My kidney function is normal or only mildly impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-9 days prior to surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-9 days prior to surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-9 days prior to surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Image Quality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: [89Zr]panitumumab-PET/MRI patientsExperimental Treatment1 Intervention

All study patients will receive \[89Zr\]Panitumumab-PET/MRI imaging.

0 / 10Eligibility 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 Squamous Cell Carcinoma (HNSCC) often involve targeting the epidermal growth factor receptor (EGFR). Monoclonal antibodies like cetuximab and panitumumab bind to EGFR on cancer cells, blocking its activation and the downstream signaling pathways that promote tumor growth and survival. This inhibition can reduce tumor proliferation and enhance the effectiveness of other treatments such as radiation and chemotherapy. For HNSCC patients, targeting EGFR is significant because it directly interferes with the cancer's growth mechanisms, potentially improving treatment outcomes and offering a more personalized therapeutic approach.

Molecularly targeted therapies in head and neck cancers.