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Clinical Trials/NCT05258383
NCT05258383
Not yet recruiting
Not Applicable

Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

Assistance Publique - Hôpitaux de Paris9 sites in 1 country320 target enrollmentMay 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Neoplasm
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
320
Locations
9
Primary Endpoint
Global analysis of 3D mapping of physical doses delivered to organs by positioning imaging.
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2023
End Date
May 14, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • IGRT (Image Guided Radiation Therapy) treatments considered: lung, pelvic (prostate), breast, ENT and pediatric cancers
  • Treatment modalities: linac + daily kV-CBCT (kilo-Volt ConeBeam CBCT) and linac + weekly kV-CBCT + daily 2-Dimensional-kilo-Volt (2D-kV) (adult: lung, prostate, breast, Ear Nose and Throat (ENT); pediatric: neuro, ENT, thorax and abdomen); Cyberknife + daily 2D-kV (adult lung); Tomotherapy + daily MV-CBCT (Mega-Volt ConeBeam CBCT) (adult prostate, breast, ENT; pediatric ENT, thorax and abdomen)

Exclusion Criteria

  • Patient who has undergone a treatment discontinuation or modification (re-planning) of treatment with an impact on the IGRT protocol.
  • Patient for which details on the imaging procedures used during treatment or DICOM files (DICOM CT, DICOM RTstruct) are incomplete will not be included

Outcomes

Primary Outcomes

Global analysis of 3D mapping of physical doses delivered to organs by positioning imaging.

Time Frame: One year after end of data collection

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.

Study Sites (9)

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