Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Brain Neoplasms

Astrocytoma

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Patients with tumors of the central nervous system (CNS) who appear to be probable candidates for future protocol entry, have disease manifestations that are of unique scientific interest, importance, and/or educational value, or who have understudied tumors with unknown or unclear natural history. Patients with known genetic syndromes at high risk of developing CNS cancers will also be evaluated.

Caregivers will be defined as anyone who patients identify as an unpaid close friend or family member who knows them well and who is involved with their day-to-day care.

Survey or Questionnaire Completion with or without Sample Submission

No Treatment

Terri S Armstrong, C.R.N.P.

Background:

Brain and spinal cord tumors are uncommon. But they contribute substantially to cancer deaths in the U.S. in children and adults. Little progress has been made in treating brain tumors. Researchers want to learn more about these tumors by studying people who have them.

Objectives:

To understand brain and spinal cord tumors better and uncover areas for further research. Also, to connect people with these tumors to doctors who can help them manage their illness and give them new treatment options.

Design:

Participants will have an initial (baseline) visit. They will have their medical history taken and undergo physical and neurological exams. They will have blood tests. They may have scans (imaging studies) of the nervous system.

If participants have urine or cerebrospinal fluid collected during their regular care, researchers may save some.

Brain tumor tissue from a prior surgery may be studied.

Genomic DNA testing will be done on samples. Results will be linked to participants medical and/or family history.

The number of study visits at NIH will depend on the wishes of participants and their local doctors.

Participants will take a brain tumor survey on a computer. They can take it all at once or in 6 separate sections.

Participants will answer questions about their general well-being. They will answer questions to learn if they have symptoms of depression or anxiety.

Physicians will discuss test results with participants. They will recommend management and treatment options.

Background:

This protocol is designed to meet an unmet need in neuro-oncology by evaluating patients with CNS tumors throughout their disease course. Data may be collected from multiple sources including medical records tests, and objective and subjective measures in patients and their caregivers. The protocol will evaluate patients with tumors of the central nervous system (CNS) who appear to be probable candidates for future protocol entry, have disease manifestations that are of unique scientific interest, importance, and/or educational value, or who have understudied tumors with unknown or unclear natural history. Patients with known genetic syndromes at high risk of developing CNS cancers will also be evaluated.

Objectives:

* To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols.
* To follow patients with tumors of the CNS that are representative of important scientific and/or clinical principles
* To follow patients with CNS tumors that are understudied or have indeterminate natural history
* To evaluate and follow patients with known genetic syndromes at high risk of developing CNS cancers

Eligibility:

* All patients greater than or equal to 18 years of age with tumors of the CNS (or a history of tumors of the CNS) of interest to the NOB, who may be candidates for an NOB trial at some point in the future.
* Patients with tumors of the CNS that are of particular interest to members of the NOB because they pose important clinical and/or scientific questions and/or shed light on important aspects of the disease.
* Patients with known genetic syndromes at high risk of developing CNS cancers are eligible.
* Patients with rare tumors of the CNS who offer an important educational benefit to neuro-oncology trainees and staff.
* Caregivers, as identified by the patient are important to assess internal and external resources (e.g., coping mechanisms), identify specific factors that help patients with primary brain tumors face the uncertainty in their daily lives.
* Ability of patient or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

Design:

* All patients will undergo an initial evaluation by a member of the NOB or by a health care provider participating in the patient s care, where past medical and oncologic histories will be obtained as well as relevant data such as neuroimaging and pathology review. A total of 10,000 participants will be accrued to this study.
* Caregivers will be defined as anyone who patients identify as an unpaid close friend or family member who knows the NHS participant well and who is involved with their day-to-day care.
* Patients may be seen at the NIH Clinical Center at varying intervals depending on the clinical situation. Data related to the natural history of their disease course and outcome will be collected at least every visit at the NIH Clinical Center in which imaging is reviewed. Patients will be seen at a clinic visit or followed remotely at a minimum of once every year.

Natural History of and Specimen Banking for People With Tumors of the Central Nervous System

Evaluation of the Natural History of and Specimen Banking for Patients With Tumors of the Central Nervous System

.BTRIS: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@dbGaP: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

National Cancer Institute (NCI)

Symptoms and General Pathology

Musculoskeletal Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Spinal Diseases

Thoracic Diseases

Thoracic Neoplasms

Bone Diseases

Respiratory Tract Diseases

Participants will have thoracic, lumbar and sacral spine lesions

Participants will undergo MRI with custom MRI spine coil

MRI with custom MRI spine coil

Yoshiya Yamada, MD

Participants will receive an MRI with a custom-built MRI coil for each participant. The purpose is to find out whether this custom-built MRI coil can help doctors see the different parts of the spine as well as or better than they can with standard CT myelograms.

Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine

Assessment of a Custom-Built MRI Coil for Spine Radiotherapy Treatment Planning

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The calculated doses to the cauda equine and spinal cord will be compared and evaluated for significant difference based upon the imaging modality (MRI coil vs CT myelogram) used to define each structure, with all other target and avoidance volumes being equal in the same patient.

Memorial Sloan Kettering Cancer Center

Infections

Skin and Connective Tissue Diseases

Osteoarthritis

Spondylitis

Spondylarthritis

Osteoarthritis, Spine

Arthritis

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Communicable Diseases

Bone Diseases, Infectious

Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.

custom pack

The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery

standard care

Annamaria Nicolini, RN

Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs. Nevertheless ,the studies available are sponsored by the industry and their results are very few. The aim of this study is to evaluate the correlation and reliability of spine surgery "custom pack" efficacy in adult patients obtained in the reduction of surgery time, relative risks, and materials wasted compared with the standard surgical field procedure practice .

Custom Pack in Spine Surgery

Surgical Field Custom Pack's Efficacy on Soft Tissue Dissecting Time Reduction, on Relative Risks and Materials Wasted, in Patients Undergoing Spine Surgery: Randomized Controlled Trial

minutes from the start of the dissection to complete bone cleaning

from the incision to the patient's sutures (minutes)

amount of open sterile materials not used

Levels of hemoglobin and hematocrit intraoperative (gas analysis before and after surgery) compared to hemoglobin and hematocrit before surgery and number of blood transfusions both intra- and postoperative.

Pain Score on the "Numeric Rating Scale". The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain.

Istituto Ortopedico Rizzoli

custom pack: Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.

Custom Pack

standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery

Standard Care

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

degenerative disease

Cristiana Forni

Soft Tissue Dissecting Time

Surgery Time

Postoperative Complications

Numbers of Materials Wasted

Blood Loss

Pain (Score on the "Numeric Rating Scale")

Length of Stay

Overall Study

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Pharmaceutical Solutions

Anesthetics

Fentanyl

Dexmedetomidine

Propofol

Analgesics, Opioid

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

dexmedetomidine infusion at the rate of 0.5 μg kg-1 hr-1, started after the induction of general anesthesia without a loading dose

saline injection only after the induction of general anesthesia

Precedex activates 2-adrenoceptors, and causes the decrease of sympathetic tone, with attenuation of the neuroendocrine and hemodynamic responses to anesthesia and surgery; it reduces anesthetic and opioid requirements; and causes sedation and analgesia. it is used before and/or during surgical

Precedex Injectable Product

mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl

Saline

dina M elgalaly, Bph

dina M elgalaly, bph

suzan M adlan, MD

suzan m Adlan, MD

The purpose of this trial is to investigate whether the effect of a low-dose dexmedetomidine infusion will decrease propofol consumption or not through a double blinded randomized controlled trial done in children cancer hospital 57357.

Spinal surgery with instrumentation is associated with the risk of iatrogenic injuries to the spinal cord. The combination of somatosensory evoked potential (SSEP) and transcranial electric motor evoked potential (tcemep) monitoring has resulted in a high degree of sensitivity in predicting postoperative neurologic outcomes. Anesthetic agents have a dose-dependent adverse effect on the ability to record evoked potential responses. Many commonly used anesthetic agents produce a dose-dependent amplitude reduction and latency prolongation of evoked responses, which may impair diagnosis of intraoperative spinal cord injury. Neuroprotection is the cornerstone of anesthetic management in neurosurgery. Preserving the quality of SSEP and motor evoked potential (MEP) and minimizing the effects of anesthetic agents on neurologic monitoring are thus investigators' priorities.

Motor-evoked potential (MEP) and somatosensory-evoked potential (SSEP) monitoring are universally used during spine surgeries, which poses risks to the functional integrity of descending motor and ascending sensory pathways.

MEP baseline recording is obtained at the start of surgery determining the amplitude. The alarming criteria for MEP are attenuation of more than 50 % in motor response amplitude for segmental tcMEP, more than 80 % for long tract tcMEP and/or abolishment of tcMEP data. Any significant change is immediately reported to the surgeons.

Prior to skin incision, SSEP baseline amplitude and latency of cortical potential peaks were recorded (N20 for upper SSEP and P37 for lower SSEP). The alarming criteria of SSEP are 50% decreased amplitude and/or more than 10% increased latency compared to baseline.

The anesthetic agents have effects on the latency and amplitude of MEP and SSEP monitoring which is dose-dependent. Total intravenous anesthesia (TIVA) with propofol and opioid is commonly recommended for surgeries that require MEP and SSEP monitoring. However, propofol administered with a large dose affects MEP monitoring.

Using dexmedetomidine has the ability of sparing hypnotics usage, especially propofol, thus facilitating MEP and SSEP monitoring with providing its beneficial effects.

The addition of dexmedetomidine (0.5 μg/kg loading dose infused over 10 min followed by a constant infusion rate of 0.5 μg/kg/h) to propofol-remifentanil regimen does not exert an adverse effect on MEP and SSEP monitoring in adult patients undergoing thoracic spinal cord tumor resection and the addition of dexmedetomidine reduces the propofol requirements for a comparable BIS measurement. Another study that supports this regimen concluded that SEPs and MEPs were maintained in the patients who are administered with the dexmedetomidine etomidate fentanyl combined anesthesia during spinal surgery. Also, it was find that dexmedetomidine changes SSEP amplitude at clinically nonsignificant levels and may be safely used in intraoperative nerve monitoring at up to 1.2mg/ kg/h .

The most attractive form of display for the calculated power spectrum during anaesthesia is the compressed spectral array (CSA), where the component power is plotted as a function of frequency for each analysed epoch. Power spectrum analysis and subsequent display of data in the CSA format provide a simplified identification of small changes in a complex EEG.

Total intravenous anesthesia (TIVA) with propofol and opioid is commonly recommended for surgeries that require MEP and SSEP monitoring. However, even propofol used with a large dose can also affect MEP monitoring. Despite its efficacy, dose-related adverse effects may occur with propofol including prolonged awakening times, lipemia, and alteration of platelet function. Additionally, although more of a concern with its prolonged use in the ICU setting, recent attention has focused on the potential development of the 'propofol infusion syndrome' during intraoperative care.

Dexmedetomidine, an alpha 2-receptor agonist, is routinely used to provide analgesia and sedation without respiratory depression in critically ill patients. Its hemodynamic stability, negligible respiratory depression, and reduction of other anesthetic and analgesic requirements make it an interesting option for intraoperative use as an adjunctive agent for general anesthesia .When dexmedetomidine is added to a propofol infusion, it decreases the dose of propofol required,provides moderate hypotension, decreases blood loss, and allows monitoring of MEPs and SSEPs. The dose of dexmedetomidine often quoted in the literature is a bolus of 1 μg kg-1 hr-1 over 10 min followed by infusion of 0.2-0.7 μg kg-1 hr-1, but this dose frequently results in bradycardia and hypotension. Recently,this study is planned to evaluate the effects of intraoperative IV infusion of a low-dose (0.5 μg kg-1 hr-1) dexmedetomidine in patients undergoing spine surgery.

Researchers have administered an intraoperative continuous infusion of lower doses of dexmedetomidine without a prior bolus.

A prospective, randomized, double-blinded clinical trial will be done on all included cases. They will be divided into two groups after induction of general anathesia using propofolwhich will be started at 100 ug/kg/min) and titrated to maintain the bispectral index at 40-60 and fentanyl will be started at 0.5ug/kg/min) and to be adjusted as needed to control the hemodynamic response to the surgical procedure and maintain the mean arterial pressure (MAP) at 55-65 mmHg. Then will randomly divided using Block Stratified Randomized Software program, after obtaining informed consent from eligible patient or his caregiver into two Arms:

Arm A: will receive dexmedetomidine infusion at the rate of 0.5 μg kg-1 hr-1, started after the induction of general anesthesia without a loading dose which is colorless solution.

Arm B :will receive placebo (saline injection) only after the induction of general anesthesia

The PI (anesthesiologist), neurosurgeon ,patient, all assisting surgeons and anesthesiologist as well operating and circulating nurse will be blinded to the study arm to which patient belongs to. Only clinical trial unit and pharmacist will be unblinded.

Dexmedetomidine Infusion on Intraoperative Propofol,Fentanyl Requirements in Spine Surgery for Pediatric Cancer Patients

the Role of Dexmedetomidine (Precedex) Infusion on Intraoperative Propofol & Fentanyl Requirements in Spine Surgery for Pediatric Cancer Patients

intraoperatively monitoring by neurophysiology in MV

intraoperatively by anesthesiologist BIS within normal range 40-60

To access whether using dexmedetomidine infusion will affect time of recovery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Natural History of and Specimen Banking for People With Tumors of the Central Nervous System	NCT02851706	Brain Cancer Brain Tumor Spine Cancer Spine Tumor Neoplasm	No Treatment	18 Years -	National Institutes of Health Clinical Center (CC)
Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine	NCT04227717	Thoracic Cancer Spine Cancer Thoracic Diseas... Spine Disease Thoracic Neopla... Spine Metastase...	MRI with custom...	18 Years -	Memorial Sloan Kettering Cancer Center
Custom Pack in Spine Surgery	NCT03050203	Bone Diseases Spine Cancer Spine Osteoarth...	custom pack standard care	18 Years - 80 Years	Istituto Ortopedico Rizzoli
Custom Pack in Spine Surgery	NCT03050203	Bone Diseases Spine Cancer Spine Osteoarth...	custom pack standard care	18 Years - 80 Years	Istituto Ortopedico Rizzoli
Dexmedetomidine Infusion on Intraoperative Propofol,Fentanyl Requirements in Spine Surgery for Pediatric Cancer Patients	NCT05493228	Spine Cancer Anesthesia	Precedex Inject... Saline	5 Years - 18 Years	Children's Cancer Hospital Egypt 57357
Dexmedetomidine Infusion on Intraoperative Propofol,Fentanyl Requirements in Spine Surgery for Pediatric Cancer Patients	NCT05493228	Spine Cancer Anesthesia	Precedex Inject... Saline	5 Years - 18 Years	Children's Cancer Hospital Egypt 57357
Natural History of and Specimen Banking for People With Tumors of the Central Nervous System	NCT02851706	Brain Cancer Brain Tumor Spine Cancer Spine Tumor Neoplasm	No Treatment	18 Years -	National Institutes of Health Clinical Center (CC)
Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine	NCT04227717	Thoracic Cancer Spine Cancer Thoracic Diseas... Spine Disease Thoracic Neopla... Spine Metastase...	MRI with custom...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for spine cancer

Every month we try and update this database with for spine cancer cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.