What side effects are associated with this type of intervention?

Common treatments for head and neck surgery, particularly those involving nerve visualization like the REVEAL 475 system, can have several side effects. These include nerve injury leading to vocal cord paralysis, which can cause voice changes or difficulty swallowing. Hypocalcemia due to parathyroid gland damage is another potential complication. Other risks include postoperative hematoma, infection, and general surgical risks such as bleeding and adverse reactions to anesthesia. The use of advanced visualization systems aims to reduce these risks by improving the precision of nerve identification and preservation during surgery.

What prior FDA approvals exist?

The REVEAL 475 system is being studied for its potential to enhance nerve visualization during head and neck surgery. While specific FDA approvals for similar nerve visualization systems in head and neck surgery are not detailed in the provided context, the da Vinci Surgical System, approved by the Pharmaceutical Affairs Agency in Japan in 2018 for oral robot-assisted surgery, represents a significant advancement in surgical technology for these procedures. Broadly, FDA-approved treatments for head and neck surgery include various surgical techniques, chemotherapies, and targeted therapies such as cetuximab, which has been shown to improve outcomes in patients with recurrent or metastatic head and neck cancer.

What other types of research exist?

Promising alternatives to the REVEAL 475 system for enhancing nerve visualization during head and neck surgery include: 1) Fluorescence-guided surgery using 5-aminolevulinic acid (5-ALA), which has been shown to improve visualization of malignant tissues. 2) Intraoperative MRI guidance, which provides real-time imaging to enhance precision during surgery. 3) Diffusion Tensor Imaging (DTI) for preoperative fiber tracking, which helps in identifying and preserving critical nerves during surgery.

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Procedure

Bevonescein for Nerve Visualization in Head and Neck Surgery

Q: What is the mechanism of action of this treatment?

The REVEAL 475 system enhances nerve visualization during head and neck surgery by using bevonescein, a fluorescent dye that highlights nerves, making them more visible to surgeons. This is important for head and neck surgery patients as it helps prevent nerve damage, reducing the risk of postoperative complications such as loss of function or sensation. Other common treatments, such as radiation therapy and chemotherapy, target cancer cells but do not specifically aid in nerve visualization.

Phase 2

Recruiting

Research Sponsored by Alume Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

Minimum of 16 years of age

Planning to undergo surgery in the Head and Neck

Must not have

Patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) < 60 mL/min

Patient has a history of prior surgery and/or radiation to the intended surgical site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special tool called the REVEAL 475 system that helps surgeons see nerves better during certain neck surgeries. Patients will receive a dye called bevonescein that makes their nerves glow under this tool. This can help surgeons avoid damaging important nerves.

Who is the study for?

This trial is for patients undergoing head and neck surgery who may benefit from enhanced nerve visualization. Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for the surgical procedure and the investigational imaging system.

What is being tested?

The study is testing the REVEAL 475 system used with bevonescein, a dye that helps surgeons see nerves more clearly during operations. The goal is to assess how well this technology works in making surgeries safer by improving nerve visibility.

What are the potential side effects?

Potential side effects are not detailed here, but they might include reactions to bevonescein or issues related to the imaging system's use. Generally, risks could involve allergic responses or complications affecting surgical outcomes.

Eligibility Criteria

Inclusion Criteria

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

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I am at least 16 years old.

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I am scheduled for surgery in my head or neck area.

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My main surgery was on my salivary gland, thyroid, or neck.

Exclusion Criteria

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

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My kidney function is reduced with a GFR less than 60 mL/min.

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I have had surgery or radiation on the area where another surgery is planned.

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My liver tests are slightly above normal.

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My heart rhythm is irregular and not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after 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

Surgeon perspective on REVEAL 475 system blue light illumination

Surgeon perspective on REVEAL 475 system ease of use

Secondary study objectives

Plasma concentration of bevonescein

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: Single Arm (Bevonescein)Experimental Treatment2 Interventions

All patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients.

0 / 7Eligibility 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 REVEAL 475 system enhances nerve visualization during head and neck surgery by using bevonescein, a fluorescent dye that highlights nerves, making them more visible to surgeons. This is important for head and neck surgery patients as it helps prevent nerve damage, reducing the risk of postoperative complications such as loss of function or sensation. Other common treatments, such as radiation therapy and chemotherapy, target cancer cells but do not specifically aid in nerve visualization.

Retreatment of Recurrent or Second Primary Head and Neck Cancer After Prior Radiation: Executive Summary of the American Radium Society Appropriate Use Criteria.Interventions for the treatment of oral and oropharyngeal cancers: surgical treatment.Prevention and treatment of trismus in head and neck cancer: A case report and a systematic review of the literature.