Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma
Fluorescein vs. Intraoperative MRI in the Resection of Malignant High Grade Glioma
This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery.
Both fluorescein and intraoperative MRI have been studied and routinely used to aid the neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely resect more tumor tissue during surgery.
This study will enroll patients with malignant high grade glioma who are going to have a surgery to remove their brain tumor.
For half of the patients, fluorescein and intraoperative MRI will be used together during surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI is used as final verification of complete, safe resection in both arms.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Extent of surgical resection of malignant high grade glioma has been established as one of the most important predictors of overall survival and six-month progression free survival. Unfortunately, it is often difficult in surgery to distinguish between tumor and normal brain. Various technologies have been developed to help the surgeon more readily safely increase extent of resection in order to achieve an improved survival after glioblastoma resection. Fluorescein has been used at some institutions for a number of years to improve visualization of high-grade gliomas enabling their better resection. Intraoperative MRI has also been developed with similar intent, allowing the patient to be imaged intraoperatively to determine extent of resection and any need for further resection prior to leaving the operating room. While there is some evidence these technologies improve extent of resection in comparison to historical controls, they have never been tested against each other in any prospective fashion.
Intraoperative MRI has significant cost and significantly increases operative time. Fluorescein is a very inexpensive injectable agent and, if as good at achieving gross total resection as intraoperative MRI, would offer patients similar surgical outcomes with less anesthetic time and cost than intraoperative MRI. This study aims to investigate the value of fluorescein or intraoperative MRI in malignant glioma patients' extent of tumor resection in a prospectively randomized manner.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Anschutz Medical Campus
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Presents with presumed or pathologically proven enhancing primary or secondary high grade glioma for surgical resection
- Eligible for gross total resection of enhancing component of tumor
- Karnofsy performance status >/= 70%
Exclusion Criteria:
- Presence of multi-focal disease
- Disease that crosses the mid-line
- History of adverse reaction to flourescein
- Known ongoing pregnancy
- Inability to grant consent
- Contraindication to perform iMRI
- Contraindication to flourescein
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm A
Flourescein plus intraoperative MRI
|
fluorescein and conventional neuro-navigation
conventional neuro-navigation and iMRI
Otros nombres:
|
|
Comparador activo: Arm B
intraoperative MRI alone
|
conventional neuro-navigation and iMRI
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Extent of resection
Periodo de tiempo: 36 hours
|
This outcome will utilize tumor volumetry of residual enhancing tumor after resection.
|
36 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Surgical time difference
Periodo de tiempo: 36 hours
|
This outcome will evaluate the difference in length of surgery time between each arm.
|
36 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David R Ormond, MD, University of Colorado, Denver
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15-1313
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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