Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests (ELISA)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

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

Treatments: Other: 3D maps of physical doses

Study type: Observational

Funder types: Other

Identifiers

NCT05258383

APHP210583 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

320 participants in 5 patient groups

Lung Neoplasm patients

Description:

Lung Neoplasm patients (adults)

Treatment:

Other: 3D maps of physical doses

Pelvic Neoplasm patients

Description:

Pelvic Neoplasm patients (adults)

Treatment:

Other: 3D maps of physical doses

Breast Cancer patients

Description:

Breast Cancer patients(adults)

Treatment:

Other: 3D maps of physical doses

Ear Nose and Throat (ENT) Cancer patients

Description:

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

Treatment:

Other: 3D maps of physical doses

Pediatric Cancer patients

Description:

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

Treatment:

Other: 3D maps of physical doses