Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Breast Neoplasms

Respiratory Aspiration

Patients are placed in the prone crawl position for whole breast irradiation and are treated with 15 x 2,67 Gy (± boost treatment if required as per international guidelines)

Breast cancer patients are placed in a prone position with the ipsilateral arm besides the body rather than extended besides the head on a dedicated couch that provides the required support for maintaining this position.

Prone crawl positioning

Liv Veldeman, MD, PhD

The aim of this study is to validate the obtained results of setup precision, comfort and setup time. The possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. Forty patients (20 with left-sided and 20 with right-sided breast carcinoma) presenting for WBI without LNI after breast-conserving surgery will be included after signing informed consent.

This is a phase II non-randomized trial, where 40 patients will be treated for breast cancer requiring whole breast irradiation as per standard of care. Patients will be simulated and treated using the novel prone crawl position to a total dose of 40.05 Gy in 15 fractions of 2.67 Gy.

The trial aims to evaluate setup precision, patient comfort and setup time in the prone crawl positioning. Feasibility of deep inspiration breathhold will be tested and dosimetric parameters evaluated.

This is done through registration of setup errors at the time of treatment, questionnaires for comfort/discomfort scoring, time registration, toxicity scoring, and dosimetric analysis in treatment planning systems.

Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery

Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging

Patient comfort as assessed by questionnaire

Time taken for setting up the patient for each fraction

The reproducibility and stability of deep inspiration breathhold is investigated by performing multiple breathhold manoevres during CT imaging at baseline, and comparing the relative geometric position of organs between on the acquired images for each patient. This will be evaluated by calculating the overlap index and dice similarity coefficien between these images.

Acute side effects due to radiotherapy using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 toxicity scoring system, scoring toxicities from grade 0 (no toxicity) to grade 5 (death)

Analysis is dose using the Dose-volume histogram (DVH) of targets and organs at risk, as obtained on CT simulation images. These DVH's are used to assess amount of radiation received by each organ and treatment target and assess the risk of treatment failure or treatment harm.

University Hospital, Ghent

Wounds and Injuries

Diseases and Abnormalities at or Before Birth

Nervous System Diseases

Rare Diseases

Syndrome

Congenital Abnormalities

Cerebrospinal Fluid Leak

Spinal Dysraphism

Neural Tube Defects

Spina Bifida Occulta

Nervous System Malformations

Tethered Cord Syndrome

Split Spinal Cord Malformation

Lipomyelomeningocele

Spina Bifida

Natriuretic Agents

Anticonvulsants

All Drugs and Chemicals

Acetazolamide

Carbonic Anhydrase Inhibitors

Enzyme Inhibitors

Diuretics

administration of Acetazolamide for 10 days following the surgery

Positioning the patient following surgery for 10 days

applying both Acetazolamide and prone positioning

Acetazolamide administration for 10 days adjust dosage with weight of the patient

prone positioning the patient for 10 days following the surgery

prone positioning

administration of acetazolamide and position the patient for 10 days following the surgery

Acetazolamide+ prone positioning

Farideh Nejat, MD

Shima Shahjouei, Student

* Purpose of study : to determine the preventive effect of acetazolamide administration, prone positioning, and the combination of both following the neurosurgical interventions in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection and wound dehiscence.
* Sample size: 144
* intervention groups:

  * Group A: Acetazolamide administration for 10 days
  * Group B: prone positioning for 10 days
  * Group C: Acetazolamide administration and prone positioning for 10 days
  * Group D: no intervention
* Period of study: Autumn 2012 to the end of winter of 2015

The purpose of this study is to evaluate the effect of Acetazolamide administration and prone positioning following lumbosacral spinal surgery in preventing cerebro-spinal fluid leakage and collection and wound dehissence in children admitted to Children Medical Center of Tehran since Autumn 2012 to the end of winter of 2015.The study is run under 4 categories of intervention:

* Group A: Acetazolamide administration for 10 days
* Group B: prone positioning for 10 days
* Group C: Acetazolamide administration and prone positioning for 10 days
* Group D: no intervention All patients are randomly assigned to these groups and when the patients faced with any of these complications, the protocol changes to Acetazolamide administration and prone positioning and the patient is considered as the failure of the protocol.

Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence

Evaluating the Effect of Acetazolamide Administration and Prone Positioning Following Lumbosacral Spinal Surgery in Preventing Cerebro Spinal Fluid Leakage and Collection and Wound Dehiscence in Children.

leakage of CSF during 1 months following surgery

collection of the CSF beneath the skin during 1 month following the surgery

dehiscence of the surgical wound during the first month following surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery	NCT05179161	Breast Cancer F...	Prone crawl pos...	18 Years -	University Hospital, Ghent
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence	NCT01867268	Fibrolipoma of ... Lipomyelomening... Split Cord Malf... Dermal Sinus Tethered Cord S... Tumor	Acetazolamide prone positioni... Acetazolamide+ ...	- 18 Years	Tehran University of Medical Sciences
Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery	NCT05179161	Breast Cancer F...	Prone crawl pos...	18 Years -	University Hospital, Ghent

Spots Global Cancer Trial Database for prone positioning