Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Glioma

Brain Neoplasms

Disease Attributes

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

Fluorescent substance to help visualize and remove as much tumor as possible without harming healthy tissue.

20 mg/kg administered once 3-5 hours prior to surgery

5-ALA (Gliolan)

Costas Hadjipanayis, MD, PhD

The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light. This may make it easier for your doctor to take out all of the tumor from your brain. The purpose of this study is to:

* Make sure that 5-ALA helps the doctor remove more of the tumor.
* Make sure 5-ALA does not cause any side effects.

If you do not want to participate in this study, your doctor(s) will still do their best to remove all of the tumor in your brain. Whether or not you join this study will not change your treatment for your brain tumor.

More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery

A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas

NX PharmaGen

National Cancer Institute (NCI)

Constantinos Hadjipanayis

Professor and Chair, Neurosurgery

Heart and Blood Diseases

Aneurysm

Intracranial Aneurysm

Vascular Diseases

Intracranial Arterial Diseases

Cerebrovascular Disorders

Central Nervous System Depressants

Analgesics

Anesthetics

Dexmedetomidine

Analgesics, Opioid

Esmolol

Adrenergic Agents

Adrenergic Antagonists

Adrenergic Agonists

Adrenergic alpha-Agonists

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Neurotransmitter Agents

Adrenergic beta-1 Receptor Antagonists

Adrenergic beta-Antagonists

Esmolol 500mcg/kg before induction in anesthesia following by 300mcg/Kg/min until extubation.

Dexmedetomidine 1mcg/Kg following by 0.7mcg/Kg/h until end of surgery.

effect of esmolol on intraoperative sympathetic control and on extubation conditions.

effect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions.

Irene Asouhidou, MD, PhD

Dimitris Zosimidis, MD

Patients undergoing intracranial procedures may experience severe hypertension and tachycardia due to intracranial hypertension and to increased release of adrenaline. Preventing perioperative sympathetic activity is of great importance. A common technique is using b-blockers like esmolol, which effectively block perioperative hemodynamic changes during intracranial surgery. A2 agonists, like Dexmedetomidine-Dex are now being used as a component of a balanced anesthesia during neurosurgical procedures. This study aimed to evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing elective craniotomy with fast track neuroanesthesia.

Patients scheduled for elective craniotomy are randomized to receive Dex 1γ/Kg over 10 minutes following by continuous infusion of Dex 0.7γ/Kg (group D) or esmolol 500mcg/Kg over 5 min following by continuous infusion of 300mcg/Kg/min (group E). Patients in both groups are subjected to a standardized anesthesia comprising of induction with propofol, fentanyl, rocuronium, and maintained with Oxygen-air: 1/1, sevoflurane and bolus fentanyl in order to access the same level of anesthesia (BIS 40-50). The hemodynamic variables at various stages of surgery (HR-heart rate, MAP-Mean arterial pressure) and recovery characteristics are also recorded. It is also performed monitoring of cerebral oximetry (INVOS).

Esmolol Versus Dexmedetomidine During Intracranial Procedures

Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures

Status of patients during emerge from anaesthesia after intracranial surgery

George Papanicolaou Hospital

Consultant anesthesiologist

All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used).

Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

Fluorescein Sodium

Cherlynn Basignani, BSN,RN,CCRC

Gabriella Anderson, BA, CCRC

Ravi Gandhi, MD

This study focuses on implementing Yellow 560 for the direct intraoperative visualization of Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop better treatment protocols, and improve the prognosis of a wide array of neurosurgical diseases. More specifically, for the patients who are undergoing surgical intervention for the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or in general residual lesion which must be corrected.

The research design is a prospective clinical study. All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). Surgery will continue with the aid of the Yellow 560 microscope with a minimum delay of 10 minutes after injection to reduce the amount of leakage of Fluorescein Sodium into the surrounding tissue.

Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

No other additional neurosurgical instruments will be used. Patients will be treated post-operatively with conventional adjunctive therapies and imaging as deemed necessary by the attending neurosurgeon for the evaluation of extent of surgery. Follow-up data (including post-operative images assessing outcomes and complications) will be collected on all patients on standard post-operative visits. Intra-operative films or recordings and all patient data may be saved and used according to HIPAA allowances.

Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

The main outcome measure of the study would be a comparison between patient pre-operative and post-operative images to evaluate the potential utility of using Fluorescein Sodium and the Yellow 560 microscope to aid in the treatment of intracranial tumors and vascular lesions.

AdventHealth

Neoplasm Metastasis

Neoplastic Processes

Anti-Infective Agents

Deoxyglucose

Antimetabolites

Antiviral Agents

Addition of 2DG to stereotactic radiosurgery. Dose escalation study.

2-deoxyglucose (2DG)

John M. Buatti, M.D.

Ionizing radiation produces cancer cell death by creating high levels of reactive oxygen species (ROS), such as superoxide and hydrogen peroxide, in irradiated cells. Cancer cells are preferentially affected by ROS. The investigators, therefore, propose that interfering with the detoxification of ROS will make radiation more toxic to cancer cells. Several cellular mechanisms exist to detoxify ROS, and glucose metabolism plays an important role in many of these mechanisms. The investigators propose that interfering with glucose metabolism will sensitize cancer cells to radiation.

The investigators' central hypothesis is that 2DG will sensitize cancer cells to ionizing radiation by inhibiting the use of glucose to detoxify reactive oxygen species produced by radiation. As an initial step to evaluate this hypothesis, the investigators have designed this phase I study.

Radiosurgery is a proven treatment option for intracranial metastases. This trial is an initial effort to potentiate the therapeutic effect of single dose stereotactic radiosurgery by combining a radiation sensitizing agent, 2DG, with radiosurgery in the treatment of intracranial metastases. Our preclinical studies indicate the degree of cancer cell radiosensitization using 2DG increases with increasing radiation dose. We therefore are interested to use 2DG with radiosurgery, since this technique allows for delivery of a large single dose of radiation.

This trial seeks to determine the maximum tolerable one time dose of 2DG that can be delivered to subjects receiving stereotactic radiosurgery. We will also measure the physiologic effects of 2DG on glucose and reactive oxygen species metabolism.

Safety Study of 2DG With Stereotactic Radiosurgery

Phase I Clinical Trial: 2DG + Stereotactic Radiosurgery (SRS) Protocol for Treatment of Intracranial Metastases

University of Iowa

Professor and Chair, Department of Radiation Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery	NCT01445691	Benign Neoplasm... Brain Cancer Brain Neoplasms... Brain Neoplasms... Brain Tumor, Pr... Brain Tumor, Re... Brain Tumors Intracranial Ne... Neoplasms, Brai... Neoplasms, Intr... Primary Brain N... Primary Maligna... Primary Maligna... Gliomas Glioblastoma	5-ALA (Gliolan)	18 Years - 80 Years	Icahn School of Medicine at Mount Sinai
Esmolol Versus Dexmedetomidine During Intracranial Procedures	NCT02563288	Intracranial An... Intracranial Ne...	Esmolol Dexmedetomidine	18 Years - 80 Years	George Papanicolaou Hospital
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions	NCT02478346	Cerebrovascular... Intracranial Ne...	Fluorescein Sod...	18 Years -	AdventHealth
Safety Study of 2DG With Stereotactic Radiosurgery	NCT00247403	Intracranial Ne... Neoplasm Metast...	2-deoxyglucose ...	21 Years -	University of Iowa

Spots Global Cancer Trial Database for intracranial neoplasms