Clinical trial NCT05258383: Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests
Official title: Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasm
Pelvic Neoplasm
Breast Cancer
Cancer, Otorhinolaryngeal
Cancer Pediatric
Keywords: Image guided radiation therapy
dosimetry
X-rays
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Commissariat A L'energie Atomique
First posted: 2022-02-28
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients (Lung Neoplasm, Breast Cancer, Cancer Ear Nose and Throat / ENT); Male patients (Lung Neoplasm, Pelvic Neoplasm, Cancer Ear Nose and Throat / ENT); Pediatric cancer patients.

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.

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

Primary outcomes:
measure: Global analysis of 3D mapping of physical doses delivered to organs by positioning imaging.
timeFrame: One year after end of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Levallois-Perret
country: France
facility: Institut de Radiothérapie et Radiochirurgie H. Hartmann
state: Hauts-de-Seine
city: Créteil
country: France
facility: Hôpital Henri Mondor - AP-HP
state: Val-de-Marne
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val-de-Marne
city: Colombes
country: France
facility: Groupe AMETHYST
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Saint-Louis - AP-HP
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière - AP-HP
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou AP-HP
city: Paris
country: France
facility: Hôpital Tenon - AP-HP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe GIRAUD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: