Prostate CancerISRARNCT06041555
MRI Guided Radiotherapy and Radiobiological Data: the ISRAR Database (Irm Sequences for Radiobiological Adaptative Radiotherapy)
An observational study of Prostate Cancer and Glioblastoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The MRI linac Unity is a major technological evolution in radiotherapy combining a linear accelerator with a 1.5T MRI (radiological quality). It allows to target the target volume more precisely and to adapt the daily dose distribution according to variations in the position and volume of the tumor, critical organs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Glioblastoma, Head and Neck Cancer
- What is being tested?
- 3 MRI sequences (T2*, IVIM and Multi Echo-Gradient), without injection, are performed
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2024to 8 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patient treated with the LINAC UNITY MRI radioguided radiotherapy for a prostate, kidney cancer, cervix, head and neck cancer or glioblastoma.
Who may be able to join
- 18years old or older
- diagnosed with prostate, kidney, cervix, head and neck cancer or glioblastoma
- indication of external radiotherapy
- treated with the Linac UNITY MRI guided radiotherapy at the centre hospitalier Lyon Sud des Hospices Civils de Lyon
- agreement of the patient to participate
- affiliated to a social security system
Who cannot join
- patient unable to keep a lying position during all the procedure
- patient under law restriction
- pregnant women or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Lyon Sud/ service de Radiothérapie Oncologie
Lyon, 69495
About this study
The MRI linac Unity is a major technological evolution in radiotherapy combining a linear accelerator with a 1.5T MRI (radiological quality). It allows to target the target volume more precisely and to adapt the daily dose distribution according to variations in the position and volume of the tumor, critical organs and the tumor response. In many studies conducted in radiology, the analysis of specific MRI sequences, particularly in radiomics, aims to characterize tumors and their sensitivity to treatment. Initial data show that in radiotherapy, it would eventually be possible to characterize the radiosensitivity of healthy and tumorous tissues. With linac 1.5T MRI, the performance of selected MRI sequences, at each session, could make it possible to identify different levels of radiosensitivity within the tumour. The reproduction of these sequences on a daily basis could make it possible to follow the variations in radiosensitivity during the treatment. The final objectives would be: 1- to adapt the doses of radiotherapy to each session with a modulation of the dose according to the daily level of intra-tumor radiosensitivity, 2- to develop Artificial Intelligence (AI) tools allowing an analysis sequences and the generation of 3D maps of intra-tumor radiosensitivity, fast and suitable for carrying out a radiotherapy session.
A first work carried out in collaboration with the CREATIS lab of the University Claude Bernard Lyon 1 (UCBL1) made it possible to generate maps of tissue oxygenation from sequences produced on the MRI linac Unity of the Hospices Civils de Lyon (T2* , IVIM, Carto T2 Multi Echo-Gradient). Hypoxia is known to be the first factor of tumor resistance to irradiation. A research program is structured in collaboration with UCBL1 in order to develop radiobiological adaptive radiotherapy approaches, based on 3D maps of intra-tumoral hypoxia and their variation during treatment. Several tumor locations were selected because of the preponderant place of MRI in tumor characterization: prostate, cervix, kidney, ENT and glioblastoma. Hypoxia is not the only factor of radioresistance. Changes in the microenvironment could also impact the sensitivity of tumor cells. The program will therefore also aim to optimize the maps initially based on hypoxia, by identifying other relevant factors to be taken into account to define intra-tumor sensitivity.
Read the detailed description
The MRI linac Unity is a major technological evolution in radiotherapy combining a linear accelerator with a 1.5T MRI (radiological quality). It allows to target the target volume more precisely and to adapt the daily dose distribution according to variations in the position and volume of the tumor, critical organs and the tumor response. In many studies conducted in radiology, the analysis of specific MRI sequences, particularly in radiomics, aims to characterize tumors and their sensitivity to treatment. Initial data show that in radiotherapy, it would eventually be possible to characterize the radiosensitivity of healthy and tumorous tissues. With linac 1.5T MRI, the performance of selected MRI sequences, at each session, could make it possible to identify different levels of radiosensitivity within the tumour. The reproduction of these sequences on a daily basis could make it possible to follow the variations in radiosensitivity during the treatment. The final objectives would be: 1- to adapt the doses of radiotherapy to each session with a modulation of the dose according to the daily level of intra-tumor radiosensitivity, 2- to develop Artificial Intelligence (AI) tools allowing an analysis sequences and the generation of 3D maps of intra-tumor radiosensitivity, fast and suitable for carrying out a radiotherapy session.
A first work carried out in collaboration with the CREATIS lab of the University Claude Bernard Lyon 1 (UCBL1) made it possible to generate maps of tissue oxygenation from sequences produced on the MRI linac Unity of the Hospices Civils de Lyon (T2* , IVIM, Carto T2 Multi Echo-Gradient). Hypoxia is known to be the first factor of tumor resistance to irradiation. A research program is structured in collaboration with UCBL1 in order to develop radiobiological adaptive radiotherapy approaches, based on 3D maps of intra-tumoral hypoxia and their variation during treatment. Several tumor locations were selected because of the preponderant place of MRI in tumor characterization: prostate, cervix, kidney, ENT and glioblastoma. Hypoxia is not the only factor of radioresistance. Changes in the microenvironment could also impact the sensitivity of tumor cells. The program will therefore also aim to optimize the maps initially based on hypoxia, by identifying other relevant factors to be taken into account to define intra-tumor sensitivity.
- Being tested
- 3 MRI sequences (T2*, IVIM and Multi Echo-Gradient), without injection, are performed
- Keywords
- LINAC, MRI, Radiotherapy, Mapping, Hypoxia, Cancer
- Medical subject headings
- Prostatic Neoplasms, Glioblastoma, Head and Neck Neoplasms, Kidney Neoplasms, Uterine Cervical Neoplasms, Hypoxia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 MRI sequences (T2*, IVIM and Multi Echo-Gradient), without injection, are performedOther
Generate 3D maps of intra-tumoral hypoxia and characterize their evolution during treatment thanks to the establishment of a prospective database of MRI sequences
| Study group | Role | What they receive |
|---|---|---|
| ISRAR Cohort | All patient treated with the LINAC UNITY MRI radioguided radiotherapy for a prostate, kidney cancer, cervix, head and neck cancer or glioblastoma. Receives: Other: 3 MRI sequences (T2*, IVIM and Multi Echo-Gradient), without injection, are performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxia mapping
Generate 3D maps of intra-tumoral hypoxia and characterize their evolution during treatment thanks to the establishment of a prospective database of MRI sequences
Measured: At the end of the sequence of treatment of each patient, that is 13 weeks after the beginning of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start8 Jan 2024
- Primary completion8 Jan 2029 (estimated)
- Study completion8 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041555
- Sponsor's protocol ID
- 69HCL23_0298
- Other IDs
- 2023-A01124-41
- Acronym
- ISRAR
- Status last verified
- Feb 2024
- First submitted
- 11 Sep 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Guided Radiotherapy and Radiobiological Data: the ISRAR Database (Irm Sequences for Radiobiological Adaptative Radiotherapy)
- ClinicalTrials.gov ID
- NCT06041555
- Acronym / sponsor ID
- ISRAR / 69HCL23_0298
- Keywords
- LINAC, MRI, Radiotherapy, Mapping, Hypoxia, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 8 Jan 2029 (estimated)
- Study completion
- 8 Jan 2029 (estimated)
- First posted
- 18 Sep 2023 (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.
The MRI linac Unity is a major technological evolution in radiotherapy combining a linear accelerator with a 1.5T MRI (radiological quality). It allows to target the target volume more precisely and to adapt the daily dose distribution according to variations in the position and volume of the tumor, critical organs and the tumor response. In many studies conducted in radiology, the analysis of specific MRI sequences, particularly in radiomics, aims to characterize tumors and their sensitivity to treatment. Initial data show that in radiotherapy, it would eventually be possible to characterize the radiosensitivity of healthy and tumorous tissues. With linac 1.5T MRI, the performance of selected MRI sequences, at each session, could make it possible to identify different levels of radiosensitivity within the tumour. The reproduction of these sequences on a daily basis could make it possible to follow the variations in radiosensitivity during the treatment. The final objectives would be: 1- to adapt the doses of radiotherapy to each session with a modulation of the dose according to the daily level of intra-tumor radiosensitivity, 2- to develop Artificial Intelligence (AI) tools allowing an analysis sequences and the generation of 3D maps of intra-tumor radiosensitivity, fast and suitable for carrying out a radiotherapy session.
A first work carried out in collaboration with the CREATIS lab of the University Claude Bernard Lyon 1 (UCBL1) made it possible to generate maps of tissue oxygenation from sequences produced on the MRI linac Unity of the Hospices Civils de Lyon (T2* , IVIM, Carto T2 Multi Echo-Gradient). Hypoxia is known to be the first factor of tumor resistance to irradiation. A research program is structured in collaboration with UCBL1 in order to develop radiobiological adaptive radiotherapy approaches, based on 3D maps of intra-tumoral hypoxia and their variation during treatment. Several tumor locations were selected because of the preponderant place of MRI in tumor characterization: prostate, cervix, kidney, ENT and glioblastoma. Hypoxia is not the only factor of radioresistance. Changes in the microenvironment could also impact the sensitivity of tumor cells. The program will therefore also aim to optimize the maps initially based on hypoxia, by identifying other relevant factors to be taken into account to define intra-tumor sensitivity.
Detailed description
The MRI linac Unity is a major technological evolution in radiotherapy combining a linear accelerator with a 1.5T MRI (radiological quality). It allows to target the target volume more precisely and to adapt the daily dose distribution according to variations in the position and volume of the tumor, critical organs and the tumor response. In many studies conducted in radiology, the analysis of specific MRI sequences, particularly in radiomics, aims to characterize tumors and their sensitivity to treatment. Initial data show that in radiotherapy, it would eventually be possible to characterize the radiosensitivity of healthy and tumorous tissues. With linac 1.5T MRI, the performance of selected MRI sequences, at each session, could make it possible to identify different levels of radiosensitivity within the tumour. The reproduction of these sequences on a daily basis could make it possible to follow the variations in radiosensitivity during the treatment. The final objectives would be: 1- to adapt the doses of radiotherapy to each session with a modulation of the dose according to the daily level of intra-tumor radiosensitivity, 2- to develop Artificial Intelligence (AI) tools allowing an analysis sequences and the generation of 3D maps of intra-tumor radiosensitivity, fast and suitable for carrying out a radiotherapy session.
A first work carried out in collaboration with the CREATIS lab of the University Claude Bernard Lyon 1 (UCBL1) made it possible to generate maps of tissue oxygenation from sequences produced on the MRI linac Unity of the Hospices Civils de Lyon (T2* , IVIM, Carto T2 Multi Echo-Gradient). Hypoxia is known to be the first factor of tumor resistance to irradiation. A research program is structured in collaboration with UCBL1 in order to develop radiobiological adaptive radiotherapy approaches, based on 3D maps of intra-tumoral hypoxia and their variation during treatment. Several tumor locations were selected because of the preponderant place of MRI in tumor characterization: prostate, cervix, kidney, ENT and glioblastoma. Hypoxia is not the only factor of radioresistance. Changes in the microenvironment could also impact the sensitivity of tumor cells. The program will therefore also aim to optimize the maps initially based on hypoxia, by identifying other relevant factors to be taken into account to define intra-tumor sensitivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ISRAR Cohort | – | Other: 3 MRI sequences (T2*, IVIM and Multi Echo-Gradient), without injection, are performedAll patient treated with the LINAC UNITY MRI radioguided radiotherapy for a prostate, kidney cancer, cervix, head and neck cancer or glioblastoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient treated with the LINAC UNITY MRI radioguided radiotherapy for a prostate, kidney cancer, cervix, head and neck cancer or glioblastoma.
Key inclusion criteria (6 listed)
- 18years old or older
- diagnosed with prostate, kidney, cervix, head and neck cancer or glioblastoma
- indication of external radiotherapy
- treated with the Linac UNITY MRI guided radiotherapy at the centre hospitalier Lyon Sud des Hospices Civils de Lyon
- agreement of the patient to participate
Key exclusion criteria (3 listed)
- patient unable to keep a lying position during all the procedure
- patient under law restriction
- pregnant women or breastfeeding
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 |
|---|---|---|
| 3 MRI sequences (T2*, IVIM and Multi Echo-Gradient), without injection, are performedGenerate 3D maps of intra-tumoral hypoxia and characterize their evolution during treatment thanks to the establishment of a prospective database of MRI sequences | Other | ISRAR Cohort |
Primary outcome
Hypoxia mapping
Time frame: At the end of the sequence of treatment of each patient, that is 13 weeks after the beginning of the treatment
Generate 3D maps of intra-tumoral hypoxia and characterize their evolution during treatment thanks to the establishment of a prospective database of MRI sequences
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Glioblastoma, run by Hospices Civils de Lyon 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier CHAPET, MD (4 78 86 42 51 ext. +33, Olivier.chapet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxia mapping (time frame: At the end of the sequence of treatment of each patient, that is 13 weeks after the beginning of the 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 20 Feb 2024.