Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

NCT05258383 | Unknown

• 1 other identifier: APHP210583
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

Image guided radiation therapy; dosimetry; X-rays

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Lung Neoplasm patients

Lung Neoplasm patients (adults)

Other: 3D maps of physical doses

Pelvic Neoplasm patients

Pelvic Neoplasm patients (adults)

Other: 3D maps of physical doses

Breast Cancer patients

Breast Cancer patients(adults)

Other: 3D maps of physical doses

Ear Nose and Throat (ENT) Cancer patients

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

Other: 3D maps of physical doses

Pediatric Cancer patients

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

Other: 3D maps of physical doses

Interventions

3D maps of physical doses 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; Ear Nose and Throat (ENT) Cancer patients; Lung Neoplasm patients; Pediatric Cancer patients; Pelvic Neoplasm patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Commissariat A L'energie Atomique: collaborator

Study Sites (9)

Institut de Radiothérapie et Radiochirurgie H. Hartmann

Levallois-Perret, Hauts-de-Seine, 92300, France

Location

Hôpital Henri Mondor - AP-HP

Créteil, Val-de-Marne, 94000, France

Location

Institut Gustave Roussy

Villejuif, Val-de-Marne, 94800, France

Location

Groupe AMETHYST

Colombes, 92250, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital Saint-Louis - AP-HP

Paris, 75010, France

Location

Hôpital La Pitié Salpêtrière - AP-HP

Paris, 75013, France

Location

Hôpital européen Georges-Pompidou AP-HP

Paris, 75015, France

Location

Hôpital Tenon - AP-HP

Paris, 75020, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Pelvic Neoplasms; Breast Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Philippe GIRAUD, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra BRUNEAU

CONTACT

331 44 84 17 12; alexandra.bruneau@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: May 15, 2023
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (9)