Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Breast Neoplasms

Lung Neoplasms

Pelvic Neoplasms

Otorhinolaryngologic Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Head and Neck Neoplasms

Otorhinolaryngologic Diseases

Ear Nose and Throat (ENT) Cancer patients (adults)

Pediatric cancer patients (under 18 years-old) : neurologic cancer , abdomen cancer, Thorax cancer, Ear Nose and Throat (ENT) Cancer

3D maps of physical doses delivered to organs by positioning imaging will be calculated based on the patient's CT image used by the treatment planning system (dosimetric calculation performed by Monte Carlo method).

3D maps of physical doses

Alexandra BRUNEAU

Ilan Darmon

Yazid Belkacemi

Céline Berthold

Jean-Marc Cosset

Gilles Crehange

Mouna Labidi

Jean-Marc SIMON

Philippe GIRAUD, MD, PhD

Antoine Schernberg

In image-guided radiotherapy (IGRT), the repeated and increasingly intensive use of on-board positioning imaging, using 2D or 3D Mega-Volt (MV) or kilo-Volt (kV) imaging devices (cone-beam or CBCT scanners), is leading the international medical community to question the potential impact of these additional doses delivered to the patient, especially in at-risk populations such as children and young adults. The doses delivered to the patient by positioning imaging are still relatively unknown, due to the lack of experimental means and software available in clinical routine to easily and accurately evaluate these doses.

The main objective is to estimate by personalized Monte Carlo calculation the physical doses delivered to the patient's organs by the onboard imaging systems during their radiotherapy treatment. The obtained imaging doses will be compared according to different irradiation scenarios commonly used in clinical routine as well as according to the treated location.

The study will consist of 2 successive steps:

* Step 1 : for a set of patients selected in the clinical centers participating in the study, 3D maps of physical doses delivered to organs by positioning imaging will be calculated based on the patient's CT image used by the treatment planning system (dosimetric calculation performed by Monte Carlo method).
* Step 2/ all the new dosimetric data, average organ doses and dose volume histogram, will be the subject of a more global analysis, which will be returned to the project's clinical partner centers.

Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Global analysis of 3D mapping of physical doses delivered to organs by positioning imaging. These analyses will aggregate the Doses Volumes Histograms (HDV) by organs of interest as well as the mean dose to 10% (D10), 50% (D50) and 90% (D90) metrics for these same organs to form an individual dosimetric report.

Commissariat A L'energie Atomique

Assistance Publique - Hôpitaux de Paris

Symptoms and General Pathology

Nervous System Diseases

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Ropivacaine

Anesthetics, Local

After induction of anesthesia, the anesthesiologist sterilizes the skin of the area to be punctured. In the test group, an Ultrasound-guided selective supraclavicular nerve block is performed using 0.5% Ropivacaine 0.1mL/kg (Maximum dose: 5mL).

The nerve block is not performed in the control group.

The nerve involved in the operation of Hickman catheter, chemoport, and Perm cath is the supraclavicular nerve. Therefore, it is judged that if only this nerve is selectively blocked, pain control can be effectively performed with a small amount of local anesthetic, and relatively few side effects occur.

Control (without intervention)

Jin-Tae Kim, MD,PhD

This prospective randomized controlled trial aims to investigate the effect of ultrasound-guided selective supraclavicular nerve block on pain control after Hickman catheter, chemoport, or Perm cath insertion in children.

Pediatric patients undergoing surgical insertion of a Hickman catheter, chemoport, or Permcath are randomly assigned to a test group (Ultrasound-guided selective supraclavicular nerve block with Ropivacaine) and a control group (Nerve block is not performed).

Immediately after induction of general anesthesia, in the test group, the supraclavicular nerve block was selectively performed using ultrasound using 0.1mL/kg of 0.5% Ropivacaine (Maximum dose: 5mL), and the nerve block was not completed in the control group. After that, a Hickman catheter, chemoport, or Permcath is surgically inserted in the usual way and allowed to recover from anesthesia.

The pain score is evaluated between 10 and 30 minutes of entering the recovery room (1 hour after the procedure) and 1 hour, 3 hours, and 24 hours after leaving the recovery room by another research team who is unaware of the group assignment. In addition, the use of additional analgesic drugs and related side effects were collected before discharge.

Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients.

Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients Receiving Hickman Catheter, Chemoport or Perm Cath Insertion : a Randomized Controlled Trial

Wong-Baker Faces Pain Rating Scale is used

Numeric rating scale is also evaluated if communication is possible

Amount per body weight of additional narcotic analgesics administered.

Amount per body weight of additionally administered non-narcotic analgesics.

Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation, etc.

Arrhythmia, Hypotension, ST change, Dizziness, Convulsion, etc.

It is confirmed by chest X-ray taken in the operating room. Diaphragmatic palsy can usually be suspected on chest X-rays showing abnormal hemidiaphragm elevation. Therefore, we will check the chest X-ray for abnormal hemidiaphragm elevation.

It is confirmed by lung ultrasound in the recovery room. Hemidiaphragm visualization by ultrasound is achieved from an anterior approach, with the patient in a supine position.

At the ultrasound, the diaphragm appears as a thick echogenic line. M-mode US may be used to measure the direction of diaphragmatic motion and the amplitude of excursion.

The two indexes usually used for the diagnosis of diaphragmatic paralysis include a Tdi value \<2 mm and a diaphragm thickening fraction (TFdi)value \<20% \[Tdi: The thickening of the diaphragm, TFdi: (thickness at the end of the inspiration - thickness at the end of expiration)/thickness at the end of expiration (in %)\].

The period from discharge from recovery room to discharge

The quality of the selective supraclavicular nerve block will be tested with loss of cold sensation using an alcohol swab.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests	NCT05258383	Lung Neoplasm Pelvic Neoplasm Breast Cancer Cancer, Otorhin... Cancer Pediatri...	3D maps of phys...	-	Assistance Publique - Hôpitaux de Paris
Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients.	NCT05015907	Cancer Pediatri...	Ropivacaine Control (withou...	3 Years - 18 Years	Seoul National University Hospital

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