What is the mechanism of action of this treatment?

Common surgical treatments, such as the use of ALM-488, involve mechanisms that enhance visualization and precision during procedures. ALM-488 is a fluorescent peptide that binds to nerves, allowing surgeons to see these critical structures in real-time. This improved visualization helps in avoiding nerve damage, reducing complications, and improving overall surgical outcomes. Such advancements are vital for surgery patients as they lead to safer procedures, quicker recoveries, and better long-term results.

What side effects are associated with this type of intervention?

Common side effects of surgical treatments, including those involving fluorescence-guided surgery (FGS) with agents like ALM-488, can include infection, bleeding, and pain at the surgical site. Additionally, patients may experience allergic reactions to the fluorescent agents, temporary changes in skin coloration, and potential damage to surrounding tissues or nerves. Post-operative complications such as delayed wound healing and scarring are also possible. It is important for patients to discuss these risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several agents for intraoperative imaging to enhance surgical precision. One notable example is indocyanine green (ICG), a fluorescent dye used for various applications including sentinel lymph node mapping and visualization of blood flow. Another example is 5-aminolevulinic acid (5-ALA), approved for fluorescence-guided resection of high-grade gliomas. These agents, like ALM-488, aim to improve surgical outcomes by providing real-time visualization of tissues, although ALM-488 specifically targets nerve visualization in head and neck surgery.

What other types of research exist?

Promising alternatives to ALM-488 for tissue imaging in surgery patients include: 1) 68Ga-DOTATATE PET/CT, which is effective for neuroendocrine tumors and provides high sensitivity and specificity. 2) 18F-FDG PET, widely used for various cancers, including lung and breast cancer, offering detailed metabolic activity imaging. 3) 124I-labeled immunoPET imaging pharmaceuticals, which are target-specific and have shown potential in preclinical and clinical evaluations for cancer detection. These alternatives offer advanced imaging capabilities that can aid in precise intra-operative visualization.

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Fluorescent Dye

ALM-488 for Nerve Visualization during Head and Neck Surgery

Phase 3

Recruiting

Led By Ryan Orosco, MD

Research Sponsored by Alume Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

The study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral) or cervical neck dissection

Must be planning to undergo surgery in the Head and Neck

Must not have

The patient has a history of prior radiation or surgery to the intended surgical site

The patient has decreased hepatic function defined as aspartate aminotransferase (AST)/serum glutamic/oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) that is higher than 20% of the institution's normal laboratory limits, and/or the patient has elevated total bilirubin that is higher than 20% of the institution's normal laboratory limits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during surgery

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests ALM-488, a tool that helps doctors see nerves better, in patients having head and neck surgery. It highlights nerves in real-time to avoid nerve damage.

Who is the study for?

This trial is for individuals at least 16 years old who are scheduled for head and neck surgery, specifically parotidectomy, thyroidectomy, or cervical neck dissection. Participants must be able to follow the study procedures and provide consent. They should use contraception during the study if sexually active. Exclusions include allergy to fluorescein or ALM-488, prior radiation/surgery in the area, uncontrolled heart rhythm issues, severe kidney impairment, unresolved high-grade toxicity from cancer therapy, severe allergies or conditions affecting study participation.

What is being tested?

The trial is testing ALM-488's ability to help surgeons see nerves more clearly during head and neck surgeries by comparing two methods: using a combination of white light reflectance with fluorescence overlay versus standard white light reflectance alone.

What are the potential side effects?

Potential side effects of ALM-488 may include allergic reactions due to sensitivity to the drug or its components. Since it involves intra-operative visualization techniques, risks associated with surgical procedures may also apply.

Eligibility Criteria

Inclusion Criteria

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

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

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

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I am at least 16 years old.

Exclusion Criteria

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

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I have had surgery or radiation on the area to be operated on.

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My liver tests are slightly above normal.

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My heart rhythm is irregular and not managed by medication.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during surgery

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

Contrast Enhancement

Length Measurement

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Group I: ALM-488-002b WLR with FL OverlayExperimental Treatment2 Interventions

Patients without a preoperative diagnosis of malignancy will be assigned to study ALM-488-002b. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR with FL Overlay.

Group II: ALM-488-002b WLR onlyExperimental Treatment2 Interventions

Group III: ALM-488-002a WLR with FL OverlayExperimental Treatment2 Interventions

Patients with a preoperative diagnosis of malignancy will be assigned to study ALM-488-002a. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR with FL Overlay.

Group IV: ALM-488-002a WLR onlyExperimental Treatment2 Interventions

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

Common surgical treatments, such as the use of ALM-488, involve mechanisms that enhance visualization and precision during procedures. ALM-488 is a fluorescent peptide that binds to nerves, allowing surgeons to see these critical structures in real-time. This improved visualization helps in avoiding nerve damage, reducing complications, and improving overall surgical outcomes. Such advancements are vital for surgery patients as they lead to safer procedures, quicker recoveries, and better long-term results.

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