Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

Breast Cancer Clinical Trial

— ELISA  

Official title:

Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05258383
• Other study ID #: APHP210583
• Secondary ID: APHP210583
• Status: Not yet recruiting
• Start date: May 15, 2023
• Est. completion date: May 14, 2025

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Alexandra BRUNEAU
• Phone: 331 44 84 17 12
• Email: alexandra.bruneau[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: May 14, 2025
• Est. primary completion date: May 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cancer Pediatric
• Lung Neoplasm
• Lung Neoplasms
• Neoplasms
• Otorhinolaryngologic Neoplasms
• Pelvic Neoplasm
• Pelvic Neoplasms

Intervention

Other:
• 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).

Locations

Country	Name	City	State
France	Groupe AMETHYST	Colombes
France	Hôpital Henri Mondor - AP-HP	Créteil	Val-de-Marne
France	Institut de Radiothérapie et Radiochirurgie H. Hartmann	Levallois-Perret	Hauts-de-Seine
France	Hôpital européen Georges-Pompidou AP-HP	Paris
France	Hôpital La Pitié Salpêtrière - AP-HP	Paris
France	Hôpital Saint-Louis - AP-HP	Paris
France	Hôpital Tenon - AP-HP	Paris
France	Institut Curie	Paris
France	Institut Gustave Roussy	Villejuif	Val-de-Marne

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Commissariat A L'energie Atomique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global analysis of 3D mapping of physical doses delivered to organs by positioning imaging.	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.	One year after end of data collection