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NCT06041555Recruiting

MRI Guided Radiotherapy and Radiobiological Data: the ISRAR Database (Irm Sequences for Radiobiological Adaptative Radiotherapy)

Source: ClinicalTrials.gov · Last updated 20 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
600 (estimated)
First submitted
11 Sept 2023
Start date
8 Jan 2024
Primary completion date
8 Jan 2029
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT06041555

What you commit to

  • Study type: Observational
  • Planned participants: 600
  • From 8 Jan 2024 to the primary completion date, 8 Jan 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • patient unable to keep a lying position during all the procedure
  • patient under law restriction
  • pregnant women or breastfeeding

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital Lyon Sud/ service de Radiothérapie Oncologie
Coordinator of this site? Confirm its status
LyonFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.