Evaluation of ExacTrac® Imaging Device for Repositioning Quality of Patients Undergoing an External ENT Radiotherapy

NCT04670991 | Unknown

• 1 other identifier: ET20-184 - ST-IGRT ORL
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Monocentric, category 2 study according to Jardé Law (minimal risks and constraints) of three prospective cohorts: Tumors located at the oropharynx, the oral cavity and the larynx-hypopharynx. The main objective is to evaluate the 3D vector of the absolute residual positioning error observed with the CBCT reference imaging, after repositioning performed with ExacTrac®. The secondary objectives are to evaluate: 1) the rate of residual errors ≥2mm (translations in all directions) and ≥2 ° (rotations in all directions) on CBCT imaging after repositionning with the ExacTrac® system; 2) the Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation; 3) the evolution of the relative position of the volume of the tumor at high risk of recurrence (CTVTHR) in relation to the spine over the entire duration of the treatment; 4) the impact of patient's weight loss, the advancement of RT and the realization of a chemotherapy / targeted therapy concomitant with RT, on the evolution of the relative position of the CTVTHR in relation to the column vertebral; 5) the dosimetric consequence of a strict bone registration on the CTVTHR coverage by calculating the post-treatment dose on the CBCT imaging.

Conditions

Cancer; Radiotherapy Side Effect

Keywords

Cancer; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Verification of the feasibility of using the ExacTrac® system as a replacement for CBCT imaging for pre-treatment repositioning of ENT sphere cancers in adult patients receiving CRMI on a linear accelerator equipped with 2 modalities

  3D vector of the absolute residual positioning error observed with the CBCT reference imaging, after repositioning performed with ExacTrac®

  Until the end of the radiotherapy treatment

Secondary Outcomes (8)

• Evaluation of residual errors rates ≥2mm (translations in all directions) and ≥2 ° (rotations in all directions) on CBCT imaging after repositionning with the ExacTrac® system

  Until the end of the radiotherapy treatment

• Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation

  Until the end of the radiotherapy treatment

• Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation

  Until the end of the radiotherapy treatment

• Evolution of the relative position of the volume of the tumor at high risk of recurrence (CTVTHR) in relation to the spine over the entire treatment duration

  Until the end of the radiotherapy treatment

• Evaluation of the impact of patient's weight loss on the evolution of the relative position of the CTVTHR in relation to the spine

  Until the end of the radiotherapy treatment

Study Arms (1)

EXATRAC imaging

OTHER

For each radiotherapy session, patient will first have an Exatrac imaging and then a CBCT imaging. Patient's repositionning will be performed accoding to CBCT data

Radiation: EXATRAC imaging

Interventions

EXATRAC imaging RADIATION

Exatrac imaging performed before the standard CBCT imaging prior to each chemotherapy session

EXATRAC imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Patient requiring an ENT radiotherapy with intensity modulation (IMR) in the oropharynx, oral cavity, hypopharynx or larynx with bilateral irradiation of the lymph node areas
• Treatment planned on an accelerator equipped with a CBCT and the ExacTract® device
• Patient affiliated to a social security system
• Informed consent dated and signed

You may not qualify if:

• Pregnant or breastfeeding woman
• Patient under totorship, curatorship or legal protection

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Leon Berard

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• BOISBOUVIER Sophie

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

METZGER Séverine

CONTACT

+33 4.78.78.27.86; severine.metzger@lyon.unicancer.fr

BOISBOUVIER Sophie

CONTACT

+33 4.78.78.07.98; sophie.boisbouvier@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, category 2 study according to Jardé Law (minimal risks and constraints) of three prospective cohorts: Tumors located at the oropharynx, the oral cavity and the larynx-hypopharynx

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: January 13, 2021
• Primary Completion: April 13, 2024
• Study Completion: October 13, 2024
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

FR (1)