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.

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.

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.

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.

ALM-488 will be infused during the pre-operative period.

ALM-488

Intra-operative real time nerve visualization will be undertaken using WLR with FL Overlay.

Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay

Intra-operative real time nerve visualization will be undertaken using WLR.

Intra-operative Visualization using White Light Reflectance (WLR)

Stacy Anthony

Brett Berman, MD

Mike Bouvet, MD

Ryan Orosoco, MD

Joseph Curry, MD

Sarah Rohde, MD

Ryan Orosco, MD

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate ALM-488.

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate ALM-488, a visualization adjunct for the real-time enhanced structural delineation of major nerves, in patients undergoing surgery of the Head and Neck.

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies.

ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery

Nerve Contrast Enhancement will be compared between WLR and WLR with FL Overlay Using the Visualization Scoring System.

Nerve Length Measurement will be compared between WLR and WLR with FL Overlay Using a Metric Ruler.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery	NCT05377554	Surgery	ALM-488 Intraoperative ... Intra-operative...	16 Years -	Alume Biosciences, Inc.
ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery	NCT05377554	Surgery	ALM-488 Intraoperative ... Intra-operative...	16 Years -	Alume Biosciences, Inc.

Spots Global Cancer Trial Database for intraoperative visualization using white light reflectance (wlr) with fluorescence (fl) overlay