Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Neoplasm Metastasis

Thalassemia

beta-Thalassemia

Hepatoblastoma

Anemia

Hemolysis

Anemia, Hemolytic

Anemia, Hemolytic, Congenital

Hematologic Diseases

Hemoglobinopathies

Genetic Diseases, Inborn

Neoplasms by Histologic Type

Beta-thalassemia

Central Nervous System Depressants

All Drugs and Chemicals

Platelet Aggregation Inhibitors

Anticonvulsants

Anesthetics

Rocuronium

Propofol

Sevoflurane

Bromides

Children 0-2 years old with oncological diseases who need an MRI under general anesthesia, will receive sugammadex 2mg/kg IV

Children 2-18 years old with oncological diseases who need an MRI under general anesthesia, will receive sugammadex 2mg/kg IV

Introductory anesthesia: sevoflurane up to 8 rev /% + Air + O2 or propofol 1% 2 mg / kg intravenously.

Maintenance: sevoflurane up to 3 rev /% + Air + O2, introduction of rocuronium bromide in a dose of 0.4 mg / kg, intravenously, as a bolus injection.

At the end of anesthesia: sugammadex in a dose of 2 mg / kg, intravenously, as a bolus injection

Sugammadex

Marina Tikhonova, MD

Eugene Pashanov, Prof. PhD

Anna Konstantinova, MD

Sugammadex is a selective antidote to muscle relaxants rocuronium bromide and vecuronium bromide. Sugammadex is a modified gamma-cyclodextrin, a compound that selectively binds rocuronium bromide and vecuronium bromide. It forms a complex with them in the blood plasma, which leads to the decrease in the concentration of muscle relaxant binding to nicotinic receptors in the neuromuscular synapse. The result is the the elimination of neuromuscular blockade caused by rocuronium bromide or vecuronium bromide. Sugammadex is used to eliminate neuromuscular blockade caused by rocuronium bromide in children aged 2 years and adolescents in standard clinical situations. The aim of the study is to prove the efficacy and safety of sugammadex in children under 2 years

Nowadays muscle relaxants are widely used in pediatric practice, but their use is fraught with numerous risks and complications. The main ones are the residual neuromuscular block and the possibility of developing a recurrence in the patient. In connection with this, the development and introduction into practical anesthesiology of new, more effective drugs for arresting the action of muscle relaxants is still relevant.

One of the them, sugammadex was recently introduced into clinical practice and provided a fundamentally new approach to the recovery of neuromuscular conduction. Often, children under two years of age need general anesthesia for MRI (prolonged stay in the device, apnea to get a high-quality image without respiratory artifacts, severe pain syndrome, severe neurological deficit, etc.). The aim of the study is the evaluation of the efficacy of sugammadex, estimated by restoring neuromuscular conduction within 0-120 seconds after bolus administration, and the safety and tolerability of sugammadex in children under two years of age. Children will be observed in the hospital during 24 hours. A group of patients from 2 to 18 years of age, in whom the drug sugammadex is used as standard therapy will be taken as a comparison group .

the Efficacy and Safety of Sugammadex in Children 0-2 Years Old

Efficacy and Safety Study of Sugammadex in Children 0-2 Years Old

De-identified individual participant data for all primary and secondary outcome measures will be made available

The time of the elimination of neuromuscular blockade (in seconds)

Assessment of all adverse events from the time of injection to the time of leaving of the MRI department

Assessment of all adverse events during next 24 hours

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Monica Sobhy

Samy AbdElAziz, PhD

Hazem Abo Zeid, PhD

Our aim is to assess the role of the gray scale and color Doppler ultrasound in diagnosis of the different pediatric neck masses .

Neck masses are a common occurrence in the pediatric population and often represent a diagnostic challenge for the clinician involved . fortunately , the vast majority of these lesions are ultimately proven to be benign in nature (1).

Even though clinical examination and patient's history are the first and indispensable steps in the initial diagnosis, the role of imaging is crucial, not only to determine whether a mass represents a true tumour or not , but also to achieve a more correct diagnosis and determine the extension of the lesion and its relation with the nearby anatomic structures (2).

Ultrasound (US) should serve as the primary initial imaging modality in children for palpable masses and assessment of superficial glandular structures. Because of the smaller neck size and less subcutaneous fat, sonographic penetration and resolution is generally improved as compared with adults (3 ).

Doppler imaging can also elucidate how flow is distributed within a mass may have diagnostic significance and help us in determining the nature of the lesion as well as it is of great importance in assessment of vascular lesions (4)

Though ultrasound is most common method used for evaluation of pediatric neck masses , and CT as well as MRI are used as an additional tool when necessary ( 3 ) , few studies have looked at the sensitivity and specificity of the different imaging modalities of the pediatric neck masses and most studies have investigated the epidemiology of the pediatric neck masses (5) which make histopathological diagnosis still the gold standard in distinguishing the etiology of pediatric neck masses and ruling out malignant disease (6)

Role of Gray Scale and Color Doppler Ultrasound in Diagnosis of Pediatric Neck Masses

determination if the lesion is solid (hyperechoic, hypoechoic or isoechoic in comparison to adjacent neck muscles) or cystic (anechoic) or mixed in consistency.

through assessment of height, length and width in centimeters.

whether it is well defined (rounded, oval or lobulated) , ill-defined(speculated or irregular).

increased or decreased vascularity depending on number of vessels and the nature of color wave (arterial or venous),

Assiut University

Principal investigator

Pain

Patients randomized in this arm will have the virtual reality headset associated to the standard care

patients randomized in this arm will have standard care.

Each patient in this treatment group will use a virtual reality headset during 3 procedures. During each procedure, the pain level will be assessed and compared with the assessed group.

Virtual reality headset

Yves REGUERRE

Emilie TECHER

Yves REGUERRE, MD

DOREVI is a monocentric randomized controlled study that will evaluate the efficacy of virtual reality helmets for pain prevention during invasive care on 78 oncologic pediatric patients. Two groups of children (between 6 and 11 and between 12 and 18 years old) will be randomized to use helmet plus standard care or standard care alone during invasive procedures (central venous catheter puncture, lumbar puncture, or bone marrow aspiration). The pain intensity will be evaluated using a visual analogic scale during three invasive procedures, and results will be compared between the patients with or without virtual reality.

intervention plus standard care versus standard care

Use of Virtual Reality in Pain Management in Pediatric Oncology

Use of Virtual Reality in Pain Management During Invasive Gestures in Pediatric Oncology: Randomized Controlled Trial

Pain will be assessed by the analogic visual scale (minimal score = 0 (no pain) , maximal score = 10 (maximal pain))

Centre Hospitalier Universitaire de la Réunion

Hematologic Neoplasms

Disease Susceptibility

This pediatric oncology study proposing a global approach integrating trio-based whole exome sequencing, somatic DNA and RNA analysis will improve the recognition of genetic predisposition and the characterization of target therapies in children with cancer.

Exome sequencing in pediatrics cancers

Pascal Pujol, PU-PH

Background. Cancer is the leading cause of death by disease in children. Most pediatric tumors differ from adult tumors in terms of biological and clinical characteristics. In children, the part of genetic determinism could be higher since the role of environmental factors may be less pronounced than in adults and that a young age at onset is a main feature of genetic cancer predisposition. Recent studies suggested that a number of genetic predisposition remains to be characterized.

Methods. Trio-Based whole exome sequencing of germline DNA from patients (children and adults diagnosed with cancers between 0 and 17 years) and parents will be performed prospectively in a multicentric study including 40 unselected cases of malignant tumor. Participating hospitals will include the CHU of Montpellier, the CHU de Nice and the AP-HP. Tumor analysis will include whole exome analysis and transcriptome for the identification of therapeutic target and contribute to confirm potential link between constitutive mutations and tumor phenotype (such as loss of expression, loss of heterozygosity).

Perspectives. This pediatric oncology study proposing a global approach integrating trio-based whole exome sequencing, somatic DNA and RNA analysis will improve the recognition of genetic predisposition and the characterization of target therapies in children with cancer.

Analyse of Tumour and Constitutional DNA for the Study of the Determinism in Child Neoplasia

A blood sample will be taken from patients and their parents in order to carry out genetic analyses.

New generation NGS Exome sequencing in trio (patient and 2 healthy parents) on an Illumina HiSeq 2000 platform using the SureSelectXT Human All Exon 50Mb, V5 kit.

Bioinformatics analysis of the data. Confirmation of mutations by Sanger sequencing (gold standard).

In case of identification of mutations in candidate genes confirmed by Sanger sequencing, we will perform functional and clinical-genetic studies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
the Efficacy and Safety of Sugammadex in Children 0-2 Years Old	NCT03728543	Anesthesia Pediatric Cance... Pediatric Tumor Pediatric Hepat... Beta-Thalassemi... Hepatic Metasta...	Sugammadex	- 18 Years	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Role of Gray Scale and Color Doppler Ultrasound in Diagnosis of Pediatric Neck Masses	NCT04856020	Pediatric Tumor		- 18 Years	Assiut University
Use of Virtual Reality in Pain Management in Pediatric Oncology	NCT05592132	Pediatric Tumor	Virtual reality...	6 Years - 18 Years	Centre Hospitalier Universitaire de la Réunion
Role of Gray Scale and Color Doppler Ultrasound in Diagnosis of Pediatric Neck Masses	NCT04856020	Pediatric Tumor		- 18 Years	Assiut University
the Efficacy and Safety of Sugammadex in Children 0-2 Years Old	NCT03728543	Anesthesia Pediatric Cance... Pediatric Tumor Pediatric Hepat... Beta-Thalassemi... Hepatic Metasta...	Sugammadex	- 18 Years	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Analyse of Tumour and Constitutional DNA for the Study of the Determinism in Child Neoplasia	NCT04471961	Pediatric Tumor Familial Cancer Solid Tumor, Ch... Hematological T...	Exome sequencin...	-	University Hospital, Montpellier

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