Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients

Официальное название

A Phase 2 Trial of Systemic Administration of Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Patients Undergoing Thyroidectomy

Обзор

Bevonescein (ALM-488) is a novel fluorescein-containing peptide that is intended as a visualization adjunct for the real-time enhanced structural delineation of major nerves during Head and Neck surgery to potentially improve patient outcomes.

Подробное описание

Patients with thyroid disease undergoing thyroidectomy will receive systemic administration of bevonescein pre-operatively for intraoperative visualization of nerves. The voice outcomes of these patients will be assessed pre-operatively and post-operatively using patient questionnaires. This study aims to show that improved nerve visualization with bevonescein will be associated with clinically meaningful improvement in voice outcomes compared to a previously published studies.

Вмешательства

• Препарат Bevonescein (ALM 488) Infusion
  Bevonescein is a synthetic peptide of 17 amino acids conjugated to a fluorescein derivative (5-carboxyfluorescein \[FAM\]) and can be visualized using instruments suitable for visualizing fluorescein. Bevonescein selectively binds to extracellular matrix of nerve tissue, increasing nerve visibility and enhancing structure delineation of nerve tissue, potentially reducing the time needed for surgeons to identify nerve tissue and reducing likelihood of nerve injury during thyroidectomy surgery.

Первичные конечные точки

• Change in Voice Handicap Index (VHI) scores [Срок оценки: At baseline (before surgery) and at 28 days post-surgery]

Вторичные конечные точки (3)

• Time to nerve identification In Thyroid Surgery [Срок оценки: Day of Surgery]
• Visualization Scoring System (VSS) scores [Срок оценки: Day of Surgery]
• NERVE Questionnaire for Surgeons [Срок оценки: Day of Surgery]

Критерии участия

Критерии включения

• Scheduled to undergo hemi thyroidectomy or total thyroidectomy for thyroid disease, including neoplasm
• Must be a minimum of 18 years old or older
• Must be able to give documented informed consent to participate in this study
• Must be a surgical candidate according to standard of care practices, as determined by the clinical judgement of the investigator
• Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry and during the course of the study. An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.
• Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:

o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.

• Willing and able to comply with all study procedures

Критерии исключения

• Previous history of surgery and/or radiation to the head, neck, or shoulder
• Abnormal cardiac rhythm not controlled with medication
• The patient has a history of drug-related anaphylactic or severe allergic reactions (CTCAE grade 3+), at the discretion of the treating investigator
• Presence or history of any hypersensitivity to bevonescein (or fluorescein) 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
• Use of any Investigational Product or investigational medical device within 30 days prior to surgery date, or requirement for any investigational agent prior to completion of all scheduled study assessments
• The subject has current evidence of renal disease defined as glomerular filtration rate (GFR) < 60 mL/min/1.73 m2

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UMPC Hillman Cancer Center — Pittsburgh

Идентификаторы

NCT: NCT07631650 · HCC 25-146

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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