Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Официальное название

Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures

Обзор

The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.

Подробное описание

Primary objective: is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.

Secondary Objective:

* To identify the optimal dose of panitumumab IRDye800 in pediatric patients * To determine efficacy of panitumumab IRDye800 to detect microscopic disease and residual tumor during surgical resection of pediatric malignant brain tumors

Pediatric subjects will undergo standard of care, histopathologically-based, surgical resection of tumor 1 to 5 days after infusion of Panitumumab-IRDye800. Intraoperative imaging will be performed using an intraoperative optical imaging devices and wide-field imaging devices.

Back table imaging of the resection tissue (ex vivo) will be also performed with the wide-field device. Ex vivo imaging of the specimens prior to and during pathological assessment will be performed using the non-invasive, close field imaging device that does not violate or destroy the tissue. Additional imaging devices used solely on the back table are not included in this record, as the data is collected is not used for medical decisions and such devices are therefore not interventions.

Pediatric subjects will be followed for 30 days following their study infusion with scheduled follow up visits on the day of surgery (Day 1 5), Day 15, and Day 30.

Вмешательства

• Препарат Panitumumab-IRDye800
  Panitumumab-IRDye800 is an imaging agent prepared as a drug-dye compound from panitumumab (Vectibix), a fully-humanized IgG2 monoclonal anti-epidermal growth factor receptor (EGFR) antibody, and IRDye800CW dye. Panitumumab-IRDye800 delivered intravenous (IV).
• Устройство Pinpoint-IR9000 endoscopic/handheld device
  Novadaq intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
• Устройство Explorer Air camera
  Surgvision intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
• Устройство PDE-NEO-II
  Hamamatsu Photonics KK intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).

Первичные конечные точки

• Toxicities (related adverse events) [Срок оценки: 30 days]

Вторичные конечные точки (2)

• Panitumumab-IRDye800 Fluorescence Intensity [Срок оценки: 5 days]
• Tumor-to-background Ratio (TBR) Sensitivity and Specificity for Optimal Dose Level [Срок оценки: 7 days]

Критерии участия

Критерии включения

• Subjects with suspected brain tumors 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 felt to be candidates for resection.
• Subjects must be eligible for resection as determined by the operating surgeon.
• Planned standard of care surgery
• Subject age 6 months to 25 years
• Life expectancy of more than 12 weeks

Критерии исключения

• Received an investigational drug within 30 days prior to first dose of Panitumumab IRDye800
• Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
• History of infusion reactions to monoclonal antibody therapies
• Pregnant or breastfeeding
• Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8 years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to 18 year old females)
• Magnesium, potassium and calcium < the lower limit of normal per institution normal lab values
• Serum creatinine > 1.5 times upper reference range
• Other lab values that in the opinion of the primary surgeon would prevent surgical resection
• Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
• Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
• Subjects not deemed to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Stanford Cancer Center — Stanford

Идентификаторы

NCT: NCT04085887 · IRB-49591 · PEDSBRN0021 · NCI-2026-04031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗