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

NCT04670991 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-03-15

No results posted yet for this study

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

Interventions

RADIATION

EXATRAC imaging

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

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • BOISBOUVIER Sophie · Centre Leon Berard

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2024-04-13
Completion
2024-10-13

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04670991 on ClinicalTrials.gov