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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during surgery

Awards & highlights

Study Summary

This trial will test whether the drug ALM-488 is effective in treating patients with a certain medical condition. The trial will be conducted at multiple centers and will compare the results of patients who receive ALM-488 to those who do not.

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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Select...

I am at least 16 years old.

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

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

Primary outcome measures

Contrast Enhancement

Length Measurement

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ALM-488

2020

Completed Phase 2

~50

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

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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