Phase 2/3 Safety and Efficacy Trial of the REVEAL 475 System for Bevonescein-Assisted Intra-Operative Visualization of Nerves in Head and Neck Surgery

Alume Biosciences, Inc.1 个研究点分布在 1 个国家目标入组 155 人开始时间: 2023年11月29日最近更新: 2026年2月25日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Alume Biosciences, Inc.
入组人数: 155
试验地点: 1
主要终点: Part 1 Phase 2 Surgeon perspective on REVEAL 475 system blue light illumination

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Part 1 Phase 2 feasibility study to characterize the feasibility of using the REVEAL 475 system by obtaining surgeon perspective on illumination and ease of use.

A Part 2 Phase 3 safety and efficacy study to evaluate conspicuity of the identified nerve due to bevonescein through the use of the Visualization Scoring System (VSS).

详细描述

Part 1 Phase 2: All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy, parathyroidectomy or neck dissection surgery. The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration.

Part 2 Phase 3: All patients receive a single dose of bevonescein 500mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy, parathyroidectomy or neck dissection surgery. During the surgery the REVEAL 475 system will be used to assess through the use of the Visualization Scoring System (VSS).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 16 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Must be a minimum of 16 years of age.
•Must be planning to undergo surgery in the Head and Neck.
•The study participant's primary surgical treatment is parotidectomy or thyroidectomy/ parathyroidectomy (unilateral or bilateral) or cervical neck dissection.
•Willing and able to provide written assent as required and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
•Willing and able to comply with all study procedures.
•Sexually active patients must be willing to use an acceptable method of contraception (e.g., double barrier method) while participating in the study and for 30 days after receiving bevonescein.
•Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had bilateral tubal ligation at least 1 year prior to screening, or who have had total hysterectomy.

排除标准

•The patient has a history of prior surgery and/or radiation to the intended surgical site.
•The patient has abnormal cardiac rhythm not controlled with medication.
•The patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) < 60 mL/min.
•The patient has decreased hepatic function defined as aspartate aminotransferase (AST)/serum glutamic/oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) that is higher than 20% of the institution's normal laboratory limits, and/or the patient has elevated total bilirubin that is higher than 20% of the institution's normal laboratory limits.*
•The patient has unresolved acute toxicity from prior anti-cancer therapy grade 2 or higher, as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.
•Alopecia, neuropathy ≤ Grade 2, as well as other nonacute and stable anti-cancer therapy toxicities are acceptable.
•The patient has a history of fluorescein allergy.
•The patient has a history of drug-related anaphylactic or severe allergic reactions.
•Presence or history of any hypersensitivity to bevonescein or its excipients that, in the judgment of the investigator, places the patient at increased risk for adverse effects.
•Presence of a concurrent disease or condition that may interfere with study participation including recent (within 6 months of screening) NYHA Class III or IV heart failure, myocardial infarction (MI) or cerebrovascular accident (CVA).
•Presence or history of any condition that, in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study.
•Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study.
•Use of any Investigational Product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
•In patients with confirmed Gilbert Syndrome, total serum bilirubin may be elevated up to 3x the institution's normal laboratory limits.