CancerST-IGRT-ORLNCT04670991
Evaluation of ExacTrac® Imaging Device for Repositioning Quality of Patients Undergoing an External ENT Radiotherapy
A study testing EXATRAC imaging in people with Cancer and Radiotherapy Side Effect, run by Centre Leon Berard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Radiotherapy Side Effect
- What is being tested?
- EXATRAC imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2021to 13 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding woman
- Patient under totorship, curatorship or legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Leon Berard
Lyon, 69008
Sophie BOISBOUVIER, sophie.boisbouvier@lyon.unicancer
About this study
Official title: Evaluation of the ExacTrac® Imaging Device for the Repositioning Quality of Patients Undergoing an External ENT Radiotherapy
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.
Read the detailed description
The radiotherapy treatment preparation requires performing a dosimetric scanner (CT) of the patient in the treatment position, with the compression. The repositioning of the ENT sphere can be complex, especially in cases where there is irradiation of the supraclavicular lymph node areas. Indeed, the height of the irradiated area can easily exceed 20cm and it is necessary to ensure a good reproducibility of the repositioning of the spine relative to the skull.
At the end of the dosimetric CT, the radiotherapist delineates the macroscopic tumor volume (GTV) as well as the clinical tumor target volumes (CTVT) and lymph nodes (CTVN), which take into account the infiltration risks of the tissue around the macroscopic tumor. Margins around the VCTs then make it possible to obtain the estimated PTV target volumes (T and N), defined so that the VCTs receive the prescribed dose despite the geometric uncertainties associated with the treatment. Contours of organs at risk (OAR) are also carried out on the dosimetric CT. Margins around the most critical OARs (eg: marrow, brainstem, chiasma and optic nerves) are then added to generate predictive target volumes of organs at risk (PRV), taking into account the geometric uncertainties. These uncertainties are separated into errors in the treatment execution (random) and errors in the treatment preparation (systematic).
Execution errors include repositioning errors, organ movements (overnight), patient anatomical changes, intrafraction movements.
Errors related to treatment preparation include repositioning errors related to patient's skin spotting of the treatment isocenter during the dosimetric CT (thanks to room lasers), errors related to the CT acquisition that sets the CTV in a given position, the CTV delineation errors.
Dosimetry is then carried out taking into account the dose criteria to be respected on the PRVs and PTVs. Whatever the protocol used [Shrinking Action Level (SAL), non-action-level (NAL) or e-NAL (extented NAL)], it must at least make it possible to guarantee that the delivered dose complies with the planned dose. An optimization of the imaging protocol must then be able to reduce the margins without compromising the treatment quality, while reducing its toxicity for the patient.
On the Centre Léon Bérard accelerators equipped with both CBCT and ExacTrac®, we would like to assess the possibility of replacing or reducing the frequency of CBCTs using ExacTrac®. The time-consuming and irradiating characteristics of CBCT encourage to propose this study, which will define the patients for whom the use of CBCT can be minimized.
In addition, if the correlation between ExacTrac® and CBCT is good, the use of ExacTrac® will make it possible to control and correct intrafraction movements, and therefore reduce the random uncertainties associated with carrying out the treatment.
The possibility of using ExacTrac® imaging for the repositioning of patients treated with RCMI ENT would allow a reduction in treatment time and therefore less discomfort for the patient, a reduction in the dose linked to repositioning imaging, follow-up and correction of patient movements during the irradiation period.
Finally, this project will enable to propose new pre-treatment imaging strategies and personalized margins according to the position of the lesions to be treated at the ENT level in order to reduce the session time when possible, and to reduce the radiation doses. X due to imaging.
The overall objective is to improve the care and quality of treatment for the patient.
- Conditions
- Cancer, Radiotherapy Side Effect
- Being tested
- EXATRAC imaging
- Keywords
- Cancer, Radiotherapy
- Medical subject headings
- Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXATRAC imagingRadiation
Exatrac imaging performed before the standard CBCT imaging prior to each chemotherapy session
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: EXATRAC imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®
Measured: 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
Percentage of differences in translations and rotations >2mm and 2 ° between the 2 systems
Measured: Until the end of the radiotherapy treatment
Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation
Average of translations and rotations obtained on the intrafraction images from ExacTrac®
Measured: Until the end of the radiotherapy treatment
Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation
Standard deviation of translations and rotations obtained on the intrafraction images from ExacTrac®
Measured: 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
Differential 3D vector representative of the differences in translation between a bone and a soft tissue repositionning obtained during the pre-treatment repositioning correlated with the treatment progress
Measured: 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
Correlation between the 3D vector of absolute residual error and the evolution of the Body Mass Index
Measured: Until the end of the radiotherapy treatment
Evaluation of the impact of the RT progress on the evolution of the relative position of the CTVTHR in relation to the spine
Correlation between the 3D vector of absolute residual error and the treatment progress
Measured: Until the end of the radiotherapy treatment
Evaluation fo the impact of a chemotherapy / targeted therapy performed concomitantly with RT, on the evolution of the relative position of the CTVTHR in relation to the spine
Correlation between the 3D vector of absolute residual error and the administration of chemotherapy / targeted therapyconcomitantly with RT
Measured: Until the end of the radiotherapy treatment
Evaluation of the dosimetric consequence of a strict bone repositionning on the CTVTHR coverage by calculating the post-treatment dose on the CBCT imaging
Calculation of the dose effectively delivered to target volumes and organs at risk, recalculated from pre-treatment CBCT images
Measured: Until the end of the radiotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start13 Jan 2021
- Primary completion13 Apr 2024 (estimated)
- Study completion13 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BOISBOUVIER Sophie, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670991
- Sponsor's protocol ID
- ET20-184 - ST-IGRT ORL
- Acronym
- ST-IGRT-ORL
- Status last verified
- Mar 2022
- First submitted
- 10 Dec 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the ExacTrac® Imaging Device for the Repositioning Quality of Patients Undergoing an External ENT Radiotherapy
- ClinicalTrials.gov ID
- NCT04670991
- Acronym / sponsor ID
- ST-IGRT-ORL / ET20-184 - ST-IGRT ORL
- Conditions
- Cancer, Radiotherapy Side Effect
- Keywords
- Cancer, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 13 Apr 2024 (estimated)
- Study completion
- 13 Oct 2024 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The radiotherapy treatment preparation requires performing a dosimetric scanner (CT) of the patient in the treatment position, with the compression. The repositioning of the ENT sphere can be complex, especially in cases where there is irradiation of the supraclavicular lymph node areas. Indeed, the height of the irradiated area can easily exceed 20cm and it is necessary to ensure a good reproducibility of the repositioning of the spine relative to the skull.
At the end of the dosimetric CT, the radiotherapist delineates the macroscopic tumor volume (GTV) as well as the clinical tumor target volumes (CTVT) and lymph nodes (CTVN), which take into account the infiltration risks of the tissue around the macroscopic tumor. Margins around the VCTs then make it possible to obtain the estimated PTV target volumes (T and N), defined so that the VCTs receive the prescribed dose despite the geometric uncertainties associated with the treatment. Contours of organs at risk (OAR) are also carried out on the dosimetric CT. Margins around the most critical OARs (eg: marrow, brainstem, chiasma and optic nerves) are then added to generate predictive target volumes of organs at risk (PRV), taking into account the geometric uncertainties. These uncertainties are separated into errors in the treatment execution (random) and errors in the treatment preparation (systematic).
Execution errors include repositioning errors, organ movements (overnight), patient anatomical changes, intrafraction movements.
Errors related to treatment preparation include repositioning errors related to patient's skin spotting of the treatment isocenter during the dosimetric CT (thanks to room lasers), errors related to the CT acquisition that sets the CTV in a given position, the CTV delineation errors.
Dosimetry is then carried out taking into account the dose criteria to be respected on the PRVs and PTVs. Whatever the protocol used [Shrinking Action Level (SAL), non-action-level (NAL) or e-NAL (extented NAL)], it must at least make it possible to guarantee that the delivered dose complies with the planned dose. An optimization of the imaging protocol must then be able to reduce the margins without compromising the treatment quality, while reducing its toxicity for the patient.
On the Centre Léon Bérard accelerators equipped with both CBCT and ExacTrac®, we would like to assess the possibility of replacing or reducing the frequency of CBCTs using ExacTrac®. The time-consuming and irradiating characteristics of CBCT encourage to propose this study, which will define the patients for whom the use of CBCT can be minimized.
In addition, if the correlation between ExacTrac® and CBCT is good, the use of ExacTrac® will make it possible to control and correct intrafraction movements, and therefore reduce the random uncertainties associated with carrying out the treatment.
The possibility of using ExacTrac® imaging for the repositioning of patients treated with RCMI ENT would allow a reduction in treatment time and therefore less discomfort for the patient, a reduction in the dose linked to repositioning imaging, follow-up and correction of patient movements during the irradiation period.
Finally, this project will enable to propose new pre-treatment imaging strategies and personalized margins according to the position of the lesions to be treated at the ENT level in order to reduce the session time when possible, and to reduce the radiation doses. X due to imaging.
The overall objective is to improve the care and quality of treatment for the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| EXATRAC imaging | Other | Radiation: EXATRAC imagingFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding woman
- Patient under totorship, curatorship or legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXATRAC imagingExatrac imaging performed before the standard CBCT imaging prior to each chemotherapy session | Radiation | EXATRAC imaging |
Primary outcome
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
Time frame: Until the end of the radiotherapy treatment
3D vector of the absolute residual positioning error observed with the CBCT reference imaging, after repositioning performed with ExacTrac®
8 secondary outcomes
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
Time frame: Until the end of the radiotherapy treatment
Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation
Time frame: Until the end of the radiotherapy treatment
Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation
Time frame: 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
Time frame: 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
Time frame: Until the end of the radiotherapy treatment
Evaluation of the impact of the RT progress on the evolution of the relative position of the CTVTHR in relation to the spine
Time frame: Until the end of the radiotherapy treatment
Evaluation fo the impact of a chemotherapy / targeted therapy performed concomitantly with RT, on the evolution of the relative position of the CTVTHR in relation to the spine
Time frame: Until the end of the radiotherapy treatment
Evaluation of the dosimetric consequence of a strict bone repositionning on the CTVTHR coverage by calculating the post-treatment dose on the CBCT imaging
Time frame: Until the end of the radiotherapy treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BOISBOUVIER Sophie principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXATRAC imaging in people with Cancer and Radiotherapy Side Effect, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact METZGER Séverine (+33 4.78.78.27.86, severine.metzger@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Until the end of the radiotherapy treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.