Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures

Обзор

This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.

Подробное описание

This study will evaluate a single intravenous dose of panitumumab-IRDye800 (pan800) in subjects with intracranial lesions who are scheduled to undergo standard-of-care neurosurgical resection. The study drug will be administered 1-5 days prior to surgery, after which participants will undergo their planned procedure with intraoperative near-infrared fluorescence imaging to assess tumor visualization. Following the infusion, subjects will be monitored for immediate adverse events, and a member of the study team will continue safety follow-up through postoperative assessments and a Day 15 follow-up contact. Participants will otherwise continue to receive standard-of-care evaluation and treatment for their intracranial disease at the discretion of their treating physicians.

Вмешательства

• Препарат Panitumumab-IRDye800
  Subjects receive a single infusion of panitumumab-IRDye800 (pan800) and will undergo near-infrared fluorescence imaging during their neurosurgical procedure 1-5 days after the infusion.

Первичные конечные точки

• Determine the safety of panitumumab-IRDye800 as an imaging agent in patients undergoing surgery for intracranial lesions. [Срок оценки: From infusion to 15 days post-infusion.]

Вторичные конечные точки (3)

• Determine the efficacy of panitumumab-IRDye800 in identifying intracranial lesions compared to surrounding normal central nervous system tissue. [Срок оценки: Within 14 days post-surgery]
• Determine the dosage of the study drug infusion to maximize the tumor-to- background ratio. [Срок оценки: Within 14 days post-surgery]
• Determine the optimal timing of the study drug infusion to maximize the tumor-to- background ratio. [Срок оценки: Within 14 days post-surgery]

Критерии участия

Критерии включения

• Subjects with intracranial lesions undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are deemed to be candidates for resection.
• Subject age ≥ 18 years.
• Adequate hematologic and end-organ function appropriate for surgery and panitumumab infusion as determined by routine preoperative evaluation or designee prior to infusion. If liver function, renal function, and hematologic laboratory test results are acceptable for elective surgery and panitumumab infusion, the patient is considered eligible for the study. Laboratory results will need to be obtained within 30 days prior to initiation of study treatment include:

• Chemistry Panel - Potassium, BUN (or urea), and Creatinine
• CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count
• Magnesium and Phosphorus
• Women of childbearing potential must have a negative pregnancy test within 7 days of study drug administration.
• Ability to understand and willingness to sign a written informed document or written informed consent via a surrogate consent rider from the patients' healthcare decision maker.

Критерии исключения

• Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment.
• History of infusion reactions to any monoclonal antibody therapies.
• Women who are currently pregnant or breastfeeding.
• Participants presenting with a baseline QTcF interval > than 480 milliseconds.
• Magnesium or phosphorus lower than normal institutional values, and subject is symptomatic.
• Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
• Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
• Patients with severe renal disease or anuria

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT07493447 · VICCHN25072

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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