Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

Not yet recruiting

• Conditions: Pelvic Neoplasm; Breast Cancer; Lung Neoplasm; Cancer, Otorhinolaryngeal; Cancer Pediatric
• Interventions: Other: 3D maps of physical doses

• Registration Number: NCT05258383
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Study Start: 2023-05-15
• Primary Completion: 2025-05-14
• Study Completion: 2025-05-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung Neoplasm patients	3D maps of physical doses	Lung Neoplasm patients (adults)
Breast Cancer patients	3D maps of physical doses	Breast Cancer patients(adults)
Pelvic Neoplasm patients	3D maps of physical doses	Pelvic Neoplasm patients (adults)
Ear Nose and Throat (ENT) Cancer patients	3D maps of physical doses	Ear Nose and Throat (ENT) Cancer patients (adults)
Pediatric Cancer patients	3D maps of physical doses	Pediatric cancer patients (under 18 years-old) : neurologic cancer , abdomen cancer, Thorax cancer, Ear Nose and Throat (ENT) Cancer

Primary Outcome Measures

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

Trial Locations

Locations (9)

Institut de Radiothérapie et Radiochirurgie H. Hartmann; 🇫🇷 Levallois-Perret, Hauts-de-Seine, France

Hôpital Henri Mondor - AP-HP; 🇫🇷 Créteil, Val-de-Marne, France

Institut Gustave Roussy; 🇫🇷 Villejuif, Val-de-Marne, France

Groupe AMETHYST; 🇫🇷 Colombes, France

Institut Curie; 🇫🇷 Paris, France

Hôpital La Pitié Salpêtrière - AP-HP; 🇫🇷 Paris, France

Hôpital Saint-Louis - AP-HP; 🇫🇷 Paris, France

Hôpital Tenon - AP-HP; 🇫🇷 Paris, France

Hôpital européen Georges-Pompidou AP-HP; 🇫🇷 Paris, France