Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04584086
Other study ID # 2020-A02023-36
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 22, 2021
Est. completion date February 27, 2023

Study information

Verified date March 2023
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective is to detect with TESLA multiparametric 3 MRI, the MRI secondary changes to protontherapy irradiation and to correlate them with TEL mapping, physical dose and biological dose. A model should thus be able to be proposed at the end of the study.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 27, 2023
Est. primary completion date February 27, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically proven or highly probable grade I meningiomas, histologically proven grade II meningiomas. - Only meningiomas of the anterior and middle floors of the base of the skull are included. - Indication of proton therapy retained in RCP and / or proton therapy technical staff (Caen site) - Patient aged 18 or over - Patient affiliated to a social security scheme - Signature of informed consent before any specific procedure related to the study Exclusion Criteria: - History of brain or face irradiation. - Implant or foreign body that can alter MRI imaging. - Contraindication to MRI (pace maker, claustrophobia ...) - Hypersensitivity to gadoteric acid, to meglumine or to any medicine containing gadolinium - Genetic radio sensitizing syndrome - Known neurological comorbidities (stroke, Parkinson's, etc.) that may impact MRI data. - Simultaneous participation in a therapeutic clinical trial - Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons - Pregnant or breastfeeding women - Persons deprived of their liberty (see article L 1121-6 CSP), - Adults who are the subject of a legal protection measure or unable to express their consent (see article L 1121-8)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MRI 3 tesla
1.5 Tesla MRIs, usually used as pre-treatment and, between 3 and 6 months after irradiation, are replaced in the study by 3 Tesla MRIs (pre-treatment and at 6 months) In addition, two additional MRIs, also performed with a 3 Tesla magnetic field, will be performed: During treatment when half of the prescribed dose has been delivered. 1 month after the end of the irradiation.

Locations

Country Name City State
France Centre François Baclesse Caen

Sponsors (1)

Lead Sponsor Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months modifications of the MRI signal on the various sequences carried out, during the study Up to 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT04894643 - Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer N/A
Recruiting NCT05364411 - HYpofractionated, Dose-redistributed RAdiotherapy With Protons and Photons in HNSCC N/A
Recruiting NCT06462378 - Proton Therapy for Locally Advanced Cervical Cancer Phase 2
Recruiting NCT05404308 - Interest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy N/A
Recruiting NCT05055648 - PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy N/A
Not yet recruiting NCT03764787 - Combination of Hypofractionated Proton Therapy With Immunotherapy Phase 1/Phase 2
Not yet recruiting NCT03765190 - Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer Phase 1/Phase 2
Recruiting NCT04832620 - Image Assisted Optimization of Proton Radiation Therapy in Chordomas and Chondrosarcomas
Recruiting NCT02632864 - Feasibility of High Dose PROton Therapy On Unresectable Primary Carcinoma Of Liver: Prospective Phase II Trial Phase 2
Completed NCT05914142 - Study on the Safety and Effectiveness of Varian ProBeam Proton Therapy Equipment in the Treatment of Solid Tumors N/A
Recruiting NCT04934293 - Virtual Reality for Children in Radiotherapy (REVER) N/A
Completed NCT02571946 - Proton Beam Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis N/A