Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

NCT ID: NCT05258383

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-05-14

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.

Conditions

Lung Neoplasm; Pelvic Neoplasm; Breast Cancer; Cancer, Otorhinolaryngeal; Cancer Pediatric

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Lung Neoplasm patients

Lung Neoplasm patients (adults)

3D maps of physical doses

Intervention Type: OTHER

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).

Pelvic Neoplasm patients

Pelvic Neoplasm patients (adults)

3D maps of physical doses

Intervention Type: OTHER

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).

Breast Cancer patients

Breast Cancer patients(adults)

3D maps of physical doses

Intervention Type: OTHER

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).

Ear Nose and Throat (ENT) Cancer patients

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

3D maps of physical doses

Intervention Type: OTHER

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).

Pediatric Cancer patients

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

3D maps of physical doses

Intervention Type: OTHER

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).

Interventions

3D maps of physical doses

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).

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Commissariat A L'energie Atomique

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe GIRAUD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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 Saint-Louis - AP-HP

Paris, , France

Hôpital La Pitié Salpêtrière - AP-HP

Paris, , France

Hôpital européen Georges-Pompidou AP-HP

Paris, , France

Hôpital Tenon - AP-HP

Paris, , France

Countries

France

Central Contacts

Alexandra BRUNEAU

Role: CONTACT

alexandra.bruneau@aphp.fr

331 44 84 17 12

Facility Contacts

Ilan Darmon

Role: primary

Yazid Belkacemi

Role: primary

Céline Berthold

Role: primary

Jean-Marc Cosset

Role: primary

Gilles Crehange

Role: primary

Mouna Labidi

Role: primary

Jean-Marc SIMON

Role: primary

Philippe GIRAUD, MD, PhD

Role: primary

Antoine Schernberg

Role: primary

Other Identifiers

APHP210583

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210583

Identifier Type: -

Identifier Source: org_study_id