Spectral Analysis Probe to Identify Glioblastoma Cells
24 de enero de 2019 actualizado por: University of Oklahoma
Pilot Study Utilizing a Spectral Analysis Probe to Identify Glioblastoma Cells in Patients With Glioblastoma Undergoing Standard Surgical Resection
This is a pilot, observational study to evaluate the intraoperative sensitivity of the Chaos Wand in detecting tumor tissue with glioblastoma disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This is a pilot study to investigate if the Chaos Wand Spectral Diagnosis Probe can be used to identify Glioblastoma (GBM) cancer cells in patients undergoing standard surgical resection.
Eligible patients who have consented to the use of the Chaos Wand will be scheduled for surgery as standard cancer care for GBM.
During the surgical procedure, the Chaos Wand Spectral Diagnosis Probe will be utilized.
Fifteen intraoperative readings and signal recordings of GBM tissue will be taken.
The wand will only be used in areas that have already been deemed in need of resection due to GBM disease.
Each site identified for spectral analysis will be marked.
The wand does not come into contact with the brain at any point during this procedure.
Following surgical resection of the GBM tumor, tissue will be collected from the same 15 sites where the Chaos Wand was used.
The pathology report will be compared with the results of spectral analysis.
Tipo de estudio
De observación
Inscripción (Actual)
12
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
The study population includes adult patients from the outpatient neurosurgery clinic or those who have presented through the University of Oklahoma emergency department and have been diagnosed with glioblastoma or are suspected of having glioblastoma based on pre-operative imaging.
The Stephenson Cancer Center will not exclude potential subjects from participating in this or any study solely on the basis of ethnic origin or socioeconomic status.
Every attempt will be made to enter all eligible patients into this protocol and therefore address the study objectives in a patient population representative of the entire patient population with GBM.
Descripción
Inclusion Criteria:
- Male or Female and over 18 years of age.
- Patients with histologically proven GBM who are newly diagnosed and eligible to undergo surgical treatment or patients who are suspected of having glioblastoma on pre-operative imaging which is subsequently confirmed by histopathology following tumor resection.
- Patients must be able to understand and willing to sign the informed consent document.
Exclusion Criteria:
- Patients with absence of glioblastoma.
- Patients who are not undergoing tumor resection.
- Patients who have prior brain radiotherapy
- Patients who have prior systemic chemotherapy
- Patients who are not willing to sign the informed consent and agree to participate.
- Patients who are pregnant or nursing
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean ratio of detecting glioblastoma cancer between the Chaos Wand spectral readings and histopathology as ground truth
Periodo de tiempo: 6 months
|
For participants newly diagnosed with glioblastoma multiforme or patients who are suspected of having glioblastoma on pre-operative imaging who consent to the use of the Chaos Wand during surgery, 15-20 spectral readings will be compared to histopathology as ground truth to measure the sensitivity of the Chaos Wand to detect glioblastoma.
For example, if a patient has 15 spectral readings but only 13 are histologically consistent with cancer, then the sensitivity of the wand would be 13/15*100 = 87%.
A mean value with standard deviation will be reported across all participants in the study.
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of participants experiencing post-operative intracranial hemorrhage following surgical resection of glioblastoma with use of the Chaos Wand during surgery
Periodo de tiempo: Up to 1 month following surgery
|
For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of intracranial hemorrhage during the post-operative hospital course will be measured.
|
Up to 1 month following surgery
|
|
Number of participants experiencing post-operative ischemic stroke following surgical resection of glioblastoma with use of the Chaos Wand during surgery
Periodo de tiempo: Up to 1 month following surgery
|
For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of ischemic stroke during the post-operative hospital course will be measured.
|
Up to 1 month following surgery
|
|
Number of participants experiencing post-operative surgical site infection following surgical resection of glioblastoma with use of the Chaos Wand during surgery
Periodo de tiempo: Up to 1 month following surgery
|
For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of surgical site infection during the post-operative hospital course will be measured.
|
Up to 1 month following surgery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Michael Sughrue, MD, University of Oklahoma
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
31 de octubre de 2017
Finalización primaria (Actual)
30 de septiembre de 2018
Finalización del estudio (Actual)
30 de septiembre de 2018
Fechas de registro del estudio
Enviado por primera vez
12 de septiembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
25 de septiembre de 2017
Publicado por primera vez (Actual)
26 de septiembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
24 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 8285
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .