Lung NeoplasmELISANCT05258383
Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests
An observational study of Lung Neoplasm and Pelvic Neoplasm, run by Assistance Publique - Hôpitaux de Paris at 9 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Neoplasm, Pelvic Neoplasm, Breast Cancer
- What is being tested?
- 3D maps of physical doses
- How many people
- 320 participants
- Where
- 9 sitesFrance
- Study dates
- 15 May 2023to 14 May 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Groupe AMETHYST
Colombes, 92250
Jean-Marc Cosset
Hôpital Henri Mondor - AP-HP
Créteil, Val-de-Marne, 94000
Yazid Belkacemi
Institut de Radiothérapie et Radiochirurgie H. Hartmann
Levallois-Perret, Hauts-de-Seine, 92300
Ilan Darmon
Institut Curie
Paris, 75005
Gilles Crehange
Hôpital Saint-Louis - AP-HP
Paris, 75010
Mouna Labidi
Hôpital La Pitié Salpêtrière - AP-HP
Paris, 75013
Jean-Marc SIMON
Hôpital européen Georges-Pompidou AP-HP
Paris, 75015
Philippe GIRAUD, MD, PhD
Hôpital Tenon - AP-HP
Paris, 75020
Antoine Schernberg
Institut Gustave Roussy
Villejuif, Val-de-Marne, 94800
Céline Berthold
About this study
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.
Read the detailed description
The study will consist of 2 successive steps:
- Step 1 : for a set of patients selected in the clinical centers participating in the study, 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).
- Step 2/ all the new dosimetric data, average organ doses and dose volume histogram, will be the subject of a more global analysis, which will be returned to the project's clinical partner centers.
- Conditions
- Lung Neoplasm, Pelvic Neoplasm, Breast Cancer, Cancer, Otorhinolaryngeal, Cancer Pediatric
- Being tested
- 3D maps of physical doses
- Keywords
- Image guided radiation therapy, dosimetry, X-rays
- Medical subject headings
- Lung Neoplasms, Pelvic Neoplasms, Breast Neoplasms, Otorhinolaryngologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D maps of physical dosesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Lung Neoplasm patients | Lung Neoplasm patients (adults) Receives: Other: 3D maps of physical doses | |
| Pelvic Neoplasm patients | Pelvic Neoplasm patients (adults) Receives: Other: 3D maps of physical doses | |
| Breast Cancer patients | Breast Cancer patients(adults) Receives: Other: 3D maps of physical doses | |
| Ear Nose and Throat (ENT) Cancer patients | Ear Nose and Throat (ENT) Cancer patients (adults) Receives: 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 Receives: Other: 3D maps of physical doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year after end of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start15 May 2023 (estimated)
- Primary completion14 May 2025 (estimated)
- Study completion14 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Responsible party
- Sponsor
- Investigators
- Philippe GIRAUD, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258383
- Sponsor's protocol ID
- APHP210583
- Other IDs
- APHP210583
- Acronym
- ELISA
- Status last verified
- Apr 2023
- First submitted
- 17 Feb 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests
- ClinicalTrials.gov ID
- NCT05258383
- Acronym / sponsor ID
- ELISA / APHP210583
- Conditions
- Lung Neoplasm, Pelvic Neoplasm, Breast Cancer, Cancer, Otorhinolaryngeal, Cancer Pediatric
- Keywords
- Image guided radiation therapy, dosimetry, X-rays
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 14 May 2025 (estimated)
- Study completion
- 14 May 2025 (estimated)
- First posted
- 28 Feb 2022 (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.
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.
Detailed description
The study will consist of 2 successive steps:
- Step 1 : for a set of patients selected in the clinical centers participating in the study, 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).
- Step 2/ all the new dosimetric data, average organ doses and dose volume histogram, will be the subject of a more global analysis, which will be returned to the project's clinical partner centers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lung Neoplasm patients | – | Other: 3D maps of physical dosesLung Neoplasm patients (adults) |
| Pelvic Neoplasm patients | – | Other: 3D maps of physical dosesPelvic Neoplasm patients (adults) |
| Breast Cancer patients | – | Other: 3D maps of physical dosesBreast Cancer patients(adults) |
| Ear Nose and Throat (ENT) Cancer patients | – | Other: 3D maps of physical dosesEar Nose and Throat (ENT) Cancer patients (adults) |
| Pediatric Cancer patients | – | Other: 3D maps of physical dosesPediatric cancer patients (under 18 years-old) : neurologic cancer , abdomen cancer, Thorax cancer, Ear Nose and Throat (ENT) Cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| 3D maps of physical doses3D 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). | Other | Breast Cancer patients, Ear Nose and Throat (ENT) Cancer patients, Lung Neoplasm patients, Pediatric Cancer patients, Pelvic Neoplasm patients |
Primary outcome
Global analysis of 3D mapping of physical doses delivered to organs by positioning imaging.
Time frame: One year after end of data collection
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Philippe GIRAUD, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasm and Pelvic Neoplasm, run by Assistance Publique - Hôpitaux de Paris at 9 sites 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 2 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Alexandra BRUNEAU (331 44 84 17 12, alexandra.bruneau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global analysis of 3D mapping of physical doses delivered to organs by positioning imaging. (time frame: One year after end of data collection). 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 18 Apr 2023.