ALM-488 for Nerve Visualization during Head and Neck Surgery
Palo Alto (17 mi)Overseen byRyan Orosco, MD
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Alume Biosciences, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
What safety data exists for ALM-488 in nerve visualization during head and neck surgery?The provided research does not contain specific safety data for ALM-488 or its use in nerve visualization during head and neck surgery. The studies focus on nerve monitoring techniques and the use of sugammadex in anesthesia, but do not mention ALM-488 or its safety profile.478911
Is ALM-488 a promising drug for nerve visualization during head and neck surgery?Yes, ALM-488 is a promising drug because it helps surgeons see nerves more clearly during head and neck surgeries, which can reduce the risk of nerve damage.123610
What data supports the idea that ALM-488 for Nerve Visualization during Head and Neck Surgery is an effective treatment?The available research does not provide specific data on ALM-488 for Nerve Visualization during Head and Neck Surgery. Instead, it discusses other methods like intraoperative nerve monitoring and fluorescently labeled peptides for nerve identification and protection during surgeries. These studies suggest that using such techniques can help identify and preserve nerves, reducing the risk of nerve damage during surgery. However, there is no direct comparison or data on ALM-488's effectiveness in these studies.256812
Do I need to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you have abnormal cardiac rhythm not controlled with medication, you may be excluded from the trial.
Eligibility Criteria
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.Inclusion Criteria
My main surgery was on my salivary gland, thyroid, or neck.
I am scheduled for surgery in the head or neck area.
I am at least 16 years old.
Exclusion Criteria
I have had surgery or radiation on the area to be operated on.
My liver tests are slightly above normal.
My heart rhythm is irregular and not managed by medication.
My kidney function is reduced with a GFR less than 60 mL/min.
Treatment Details
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.
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
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 only.
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
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 only.
ALM-488 is already approved in United States for the following indications:
🇺🇸 Approved in United States as ALM-488 for:
- Intra-operative nerve visualization in head and neck surgery
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of California San DiegoLa Jolla, CA
Vanderbilt University Medical CenterNashville, TN
University of PennsylvaniaPhiladelphia, PA
Thomas Jefferson UniversityPhiladelphia, PA
More Trial Locations
Loading ...
Who is running the clinical trial?
Alume Biosciences, Inc.Lead Sponsor
ErgomedIndustry Sponsor
References
A newly designed nerve monitor for microneurosurgery: bipolar constant current nerve stimulator and movement detector with a pressure sensor. [2019]The authors describe a newly designed nerve monitor which is useful for numerous microneurosurgical procedures. Standard bipolar forceps are used to apply constant current stimulation. Muscle contraction evoked by the stimulation is detected by a small disc-shaped pressure sensor taped to the overlying skin. The responses are monitored both quantitatively on a liquid crystal display and qualitatively through an on-off auditory signal. Surgery can proceed without interruption. This apparatus can safely and reliably monitor the facial nerve, nerves involved in eye movements, lower cranial nerves and spinal nerves. This portable system weights only 1.8 kg and can easily be used by a neurosurgeon.
Systematic facial nerve monitoring in middle ear and mastoid surgeries: "surgical dehiscence" and "electrical dehiscence". [2019]To evaluate and systemize intraoperative facial nerve monitoring (IOFNM) in middle ear and mastoid surgeries.
New methodology for facial nerve monitoring in extracranial surgeries of vascular malformations. [2018]To develop a more reliable methodology for monitoring the facial nerve in surgeries of vascular malformations where the extracranial segment of the nerve is at risk.
Motor nerves of the head and neck that are susceptible to damage during dermatological surgery. [2014]As the incidence of non melanoma skin cancer rises, dermatologists will increasingly be called upon to perform excisions in the head and neck region. Damage to the motor nerves of the head and neck represents an important adverse event for patients, and a source of litigation for surgeons. Understanding the anatomy of this region is key to counselling patients about the possibility of motor nerve injury associated with particular skin surgical procedures. We describe the anatomy of the motor nerves of the head and neck that are most vulnerable to injury during dermatological surgery. The consequences of injury are outlined, and the surface anatomy and anatomical landmarks that may be used to identify the relevant danger zones are described.
Facial nerve monitoring during parotidectomy: a systematic review and meta-analysis. [2021]To determine the effectiveness of intraoperative facial nerve monitoring (FNM) in preventing immediate and permanent postoperative facial nerve weakness in patients undergoing primary parotidectomy.
Improved facial nerve identification during parotidectomy with fluorescently labeled peptide. [2018]Additional intraoperative guidance could reduce the risk of iatrogenic injury during parotid gland cancer surgery. We evaluated the intraoperative use of fluorescently labeled nerve binding peptide NP41 to aid facial nerve identification and preservation during parotidectomy in an orthotopic model of murine parotid gland cancer. We also quantified the accuracy of intraoperative nerve detection for surface and buried nerves in the head and neck with NP41 versus white light (WL) alone.
The feasibility of sugammadex for general anesthesia and facial nerve monitoring in patients undergoing parotid surgery. [2018]The use of neuromuscular blocking agent (NMBA) during anesthesia may interfere with facial nerve monitoring (FNM) during parotid surgery. Sugammadex has been reported to be an effective and safe reversal of rocuronium-induced neuromuscular block (NMB) during surgery. This study investigated the feasibility and clinical effectiveness of sugammadex for NMB reversal during FNM in Parotid surgery. Fifty patients undergoing parotid surgery were randomized allocated into conventional anesthesia group (Group C, n = 25) and sugammadex group (Group S, n = 25). Group C did not receive any NMBA. Group S received rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at skin incision. The intubating condition and influence on FNM evoked EMG results were compared between groups. The intubation condition showed significantly better in group S patients than C group patients (excellent in 96% v.s. 24%). In group S, rapid reverse of NMB was found and the twitch (%) recovered from 0 to >90% within 10 min. Positive and high EMG signals were obtained in all patients at the time point of initial facial nerve stimulation in both groups. There was no significant difference as comparing the EMG amplitudes detected at the time point of initial and final facial nerve stimulation in both groups. Implementation of sugammadex in anesthesia protocol is feasible and reliable for successful FNM during parotid surgery.
Intraoperative monitoring of marginal mandibular nerve during neck dissection. [2019]The purpose of this study was to assess the efficacy of intraoperative nerve integrity monitoring (NIM) to prevent marginal mandibular nerve injuries during neck dissection.
Electromyographic Response of Facial Nerve Stimulation Under Partial Neuromuscular Blockade During Resection of Vestibular Schwannoma. [2020]To evaluate whether use of partial nondepolarizing neuromuscular blocking agents, at a train-of-four level 1, compromise facial nerve monitoring during vestibular schwannoma (VS) resection.
Facial Nerve Branching Patterns Vary With Vascular Anomalies. [2020]At our institution, in vivo facial nerve mapping (FNM) is used during vascular anomaly (VAN) surgeries involving the facial nerve (FN) to create an FN map and prevent injury. During mapping, FN anatomy seemed to vary with VAN type. This study aimed to characterize FN branching patterns compared to published FN anatomy and VAN type.
Continuous vagal intraoperative neuromonitoring during video-assisted thoracoscopic surgery for left lung cancer: its efficacy in preventing permanent vocal cord paralysis. [2022]We investigated the safety and efficacy of continuous intraoperative neuromonitoring (CIONM) during video-assisted thoracoscopic lobectomy for left lung cancer in preventing recurrent laryngeal nerve injury.
Predicting postoperative facial nerve paralysis by using intraoperative nerve monitoring during parotid surgery. [2023]To investigate a method for predicting postoperative facial nerve paralysis (POFNP) during parotid surgery using intraoperative nerve monitoring (IONM).