Clinical trial · Interventional
Evaluation of ExacTrac® Imaging Device for Repositioning Quality of Patients Undergoing an External ENT Radiotherapy
Evaluation of the ExacTrac® Imaging Device for the Repositioning Quality of Patients Undergoing an External ENT Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EXATRAC imaging | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- EXATRAC imaging
- description
- 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
- interventionNames
- Radiation: EXATRAC imaging
Primary outcomes (1)
- measure
- 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
- timeFrame
- Until the end of the radiotherapy treatment
- description
- 3D vector of the absolute residual positioning error observed with the CBCT reference imaging, after repositioning performed with ExacTrac®
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant or breastfeeding woman * Patient under totorship, curatorship or legal protection
References
Publications (0)
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