Brain Tumor Clinical Trial
Official title:
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
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05023434 -
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
|
||
| Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
| Completed |
NCT02768389 -
Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
|
Early Phase 1 | |
| Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT03286335 -
Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy
|
N/A | |
| Recruiting |
NCT05968053 -
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
|
||
| Recruiting |
NCT05358340 -
Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions
|
N/A | |
| Recruiting |
NCT03276676 -
[18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors
|
Phase 2 | |
| Completed |
NCT02851355 -
Follow-up Survey of Patients Who Were Treated for Medulloblastoma or Primitive Neuroectodermal Tumors of the Central Nervous in Norway
|
||
| Completed |
NCT02558569 -
The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block
|
Phase 4 | |
| Completed |
NCT02409121 -
A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers
|
N/A | |
| Completed |
NCT02713087 -
Vasopressor Effects in Anesthetized Patients
|
Phase 4 | |
| Terminated |
NCT02674945 -
Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
|
||
| Withdrawn |
NCT02165995 -
Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery
|
N/A | |
| Completed |
NCT01171469 -
Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Progressive Malignant Brain Tumor
|
Phase 1 | |
| Withdrawn |
NCT01202539 -
Real-time Assessment of Frameless Intrafraction Motion
|
||
| Terminated |
NCT01044966 -
A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00760409 -
Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI
|
N/A | |
| Completed |
NCT00503204 -
Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour
|
Phase 1 |