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.

Ergomed

Alume Biosciences, Inc.

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Melanoma

Head and Neck Neoplasms

Participants diagnosed with head and neck cancer who are candidates for definitive surgical resection of the primary tumor and who are candidates for eHNS.

Christ Holsinger, MD

The goal of this data review research study is to create a registry database using information (data) collected from patients who have had Endoscopic Head and Neck Surgery (eHNS). Researchers want to use the registry database to learn more about short-term and long-term outcomes for patients who have eHNS.

1.1 Primary Objective: To develop a registry database of patients who have had eHNS.

1.2 Secondary Objective: To evaluate short-term oncologic parameters and functional outcomes, operative for patients undergoing eHNS performed at M.D. Anderson Cancer Center (MDACC).

1.3 Tertiary Objective: To collect data on long-term oncologic outcomes including local and distant failure and survival following eHNS.

Information from medical records will be collected and entered into the registry database at M. D. Anderson Cancer Center for future research related to cancer.

The information collected from medical records will include, but is not limited to, medical history, sex, age, race, gender, type and stage of disease, type of treatment(s) you have received, radiology reports, surgical and pathological reports, the results of any test(s), treatment(s) and/or surgery performed.

This is a registry study evaluating endoscopic head and neck surgery. The data from the surgical resection will be descriptive. Comparisons will be made to non-robotic, open historical controls and patients treated with radiation therapy, based on literature reports.

TEST: Registry for Endoscopic Head and Neck Surgery

Transoral Endoscopic Surgery Trial (TEST): A Registry for Endoscopic Head and Neck Surgery (eHNS)

Registry database using information (data) collected from participants who have had eHNS.

M.D. Anderson Cancer Center

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplasm, Residual

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Neoplastic Processes

Oral Squamous Cell Carcinoma

biological assessment on operating bed to detect residual circulating tumor DNA

Circulating tumor DNA detection

Lise-Marie Roussel, MD

Doriane Richard, PhD

Sophie Deneuve, Md

Lise-Marie Roussel, Md

The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.

Squamous cell carcinomas of the oral cavity have a poor prognosis. The 5-year loco-regional recurrence rate is 45%. Surgery remains the standard treatment. The presence of invasive or insufficient surgical margins is an important histopronostic factor.

Current tools for intraoperative detection of insufficient margins have a very low sensitivity of around 10%. The aim here is to develop a more sensitive tool by looking for the presence of residual tumour DNA in the entire operating bed after squamous cell carcinoma excision

Contribution of Residual Tumour DNA Testing on the Surgical Bed

Contribution of Residual Tumour DNA Testing on the Surgical Bed of Squamous Cell Carcinomas of the Oral Cavity

Proportion of patients with residual tumour DNA on the operating bed according to the presence or absence of adverse histological factors

Proportion of patients with circulating tumour DNA and in the cervical lymphatic drainage fluid or circulating blood according to the presence or absence of residual tumour DNA on the operating bed

Centre Henri Becquerel

Squamous Cell Carcinoma of Head and Neck

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Mitogens

patients with operable head and neck squamous cell carcinoma

patients treated by neck ansd head surgery for a non-oncological disease

patients treated before surgery with 3 doses of neoadjuvant cetuximab

Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.

head and neck surgery

Jean-Pascal Machiels, PhD

The obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome

Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Manual ventilation with Mapleson C-circuit

A portable mechanical ventilator/resuscitator for medical personnel in the hospital, ambu-lance, fire, and police services.

Pneupac VR1

Jennifer Boston

Following major head and neck surgery it may be necessary to keep patients intubated and ventilated for at least 12 hours to allow the swelling associated with the operation to subside. Therefore patients (participants) are transferred to the intensive care unit anaesthetised, in-tubated and ventilated. Current practice is that patients are manually ventilated, by hand, during transfer from the operating theatre to the intensive care unit.

Following major head and neck surgery it may be necessary to keep patients intubated and ventilated for at least 12 hours to allow the swelling associated with the operation to subside. Therefore patients (participants) are transferred to the intensive care unit anaesthetised, in-tubated and ventilated. Current practice is that patients are manually ventilated, by hand, during transfer from the operating theatre to the intensive care unit.

Studies show that use of manual ventilation causes variability in respiratory parameters and blood gas values due to inconsistent ventilation. A study in 2003 found that portable ventila-tor provided more consistent ventilation and patients were less likely to have a disparity in their blood gases, oxygenation and ventilation.. However, conventional ventilators are bulky, heavy, expensive and few and far between in the hospital and, in particular, the pre-hospital setting. The Pneupac VR1 ventilator is simple to use, small, portable and durable. It is easy to clean, low cost, light weight and magnetic resonance imaging (MRI) compatible.

The study will aim to directly compare the efficiency and efficacy (ventilation rate and tidal volumes) of manual ventilation against a new device, VR-1 portable ventilator, by Smith-Medical. The device is CE approved. The RCT will compare the efficacy and efficiency during transfer of the patient from theaters to intensive care in our establishment. The endpoint will be arrival to the intensive care unit (ICU) and transfer onto the ICU ventilator. This will be measured by collecting the pCO2, taken from an already in-situ arterial blood gas (ABG), at two time points - (a) just before patient transfer from theaters to the intensive care unit and (b) upon arrival at the intensive care unit and just prior to transfer onto the ITU ventilator.

RCT: Compare - Pneupac VR1 to Manual Ventilation in Intubated Patients

A Randomised Control Trial to Compare the Pneupac VR1 Portable Ventilator and Manual Ven-tilation Via a Mapleson C- Circuit During the Intra-hospital Transfers of Intubated Patients

The difference in pCO2 between patients in the control and the intervention group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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.
TEST: Registry for Endoscopic Head and Neck Surgery	NCT01412749	Head and Neck C...		-	M.D. Anderson Cancer Center
Contribution of Residual Tumour DNA Testing on the Surgical Bed	NCT05934929	Squamous Cell C...	Circulating tum...	18 Years -	Centre Henri Becquerel
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery	NCT01280318	Head and Neck S... Growth Factor Surgery	head and neck s...	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.
RCT: Compare - Pneupac VR1 to Manual Ventilation in Intubated Patients	NCT02782871	Cancer	Pneupac VR1	18 Years - 100 Years	Brighton and Sussex University Hospitals NHS Trust
TEST: Registry for Endoscopic Head and Neck Surgery	NCT01412749	Head and Neck C...		-	M.D. Anderson Cancer Center
Contribution of Residual Tumour DNA Testing on the Surgical Bed	NCT05934929	Squamous Cell C...	Circulating tum...	18 Years -	Centre Henri Becquerel
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery	NCT01280318	Head and Neck S... Growth Factor Surgery	head and neck s...	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Spots Global Cancer Trial Database for head and neck surgery