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

Gland and Hormone Related Diseases

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Head and Neck Neoplasms

Parotid Neoplasms

Endocrine Gland Neoplasms

Endocrine System Diseases

Salivary Gland Neoplasms

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Parotid Diseases

Salivary Gland Diseases

Oral Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

This arm of the study will include Dose Escalation/De-Escalation cohorts of ALM-488.

This arm of the study will include Dose Timing cohorts of ALM-488.

ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head \& neck surgery.

This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an intravenous (IV) infusion to patients undergoing head \& neck surgery. The study will also characterize the pharmacokinetics of ALM-488 in this subject population and determine the dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence characteristics.

This is a Phase 1/Phase 2 study in patients undergoing Head \& Neck Surgery.

A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery

Incidence of ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Concentration of ALM-488 in blood at varying times following ALM-488 administration.

To determine the recommended dose of ALM-488.

To evaluate the effect of timing of administration of ALM-488.

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Jason B. Wynberg, MD, FACS

Our objective is to evaluate the clinical outcomes for the anatomic radical perineal prostatectomy (RPP) for the surgical management of prostate cancer. We will report the perioperative, oncologic, and functional outcomes in patients undergoing the radical perineal prostatectomy at our institution.

The purpose of our study is to evaluate perioperative, oncologic, and functional outcomes for the anatomic radical perineal prostatectomy. The anatomic radical perineal prostatectomy is standard-of-care surgical approach to the surgical management of localized prostate cancer. The operative technique selected for radical prostatectomy is largely based on patient preference after appropriate counseling, and surgeon recommendation based on surgical considerations and surgeon experience. Outcome data for the anatomic radical perineal prostatectomy will represent a valuable addition to the published body of literature. Our study is a prospective clinical outcome data collection and analysis and we will be looking at data within several domains. First, perioperative data will be collected to evaluate the OR time, blood loss, surgical complications, and length of hospital stay for the anatomic radical perineal prostatectomy. Second, oncologic efficacy of this procedure will be reported, based on margin status of surgical specimens, which will be correlated with tumor features (Gleason score, tumor volume, pre-op PSA score). Third, functional outcomes will be evaluated by comparing urinary, sexual, and bowel function in the pre-op and post-op settings. This third domain will be accomplished by employing the following validated questionnaires (attached - SHIM, IPSS, and EPIC-26). These questionnaires will be filled out at 3 time-points: pre-op, and at 3 months and 12 months post-operatively.

Study of Anatomic Nerve Sparing Radical Perineal Prostatectomy

Clinical Outcomes for Anatomic Nerve Sparing Radical Perineal Prostatectomy

Maimonides Medical Center

Blood and Lymph Conditions

Immune System Diseases

Carcinoma

Lymphoma

Adenocarcinoma

Facies

Soft Tissue Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy, patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.

Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.

Surgical resection

Theo Ruers, MD

Investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. medical blade) would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates.

The aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery.

Primary Objective:

The goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue.

Secondary Objective:

During the measurement procedure, possible improvements of the measurement hardware will be recorded and the handling of the optical spectroscopy system during surgery will be evaluated.

Optical Detection of Peripheral Nerve Bundles During Surgery

In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study

Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations

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.
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.
A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery	NCT04420689	Parotid Neoplas... Thyroid Neoplas... Head and Neck N... Surgery Nerve Injury Imaging	ALM-488	18 Years -	Alume Biosciences, Inc.
A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery	NCT04420689	Parotid Neoplas... Thyroid Neoplas... Head and Neck N... Surgery Nerve Injury Imaging	ALM-488	18 Years -	Alume Biosciences, Inc.
Study of Anatomic Nerve Sparing Radical Perineal Prostatectomy	NCT00922818	Prostate Cancer		18 Years -	Maimonides Medical Center
Optical Detection of Peripheral Nerve Bundles During Surgery	NCT01731379	Malignant Lymph... Malignant Lymph... Malignant Lymph... Carcinoma of Pa... Colon Rectal Ca... Tumor of Soft T...	Surgical resect...	18 Years -	Philips Healthcare

Spots Global Cancer Trial Database for nerve

Every month we try and update this database with for nerve cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nerve

Every month we try and update this database with for nerve cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nerve cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.