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Radiotherapy of Multiple Brain Metastases Using AGuIX®
Sponsor: University Hospital, Grenoble
Summary
This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT). The main endpoint will be evaluated by a blinded endpoint committee.
Official title: Radiotherapy of Multiple Brain Metastases Using AGuIX® Gadolinium-chelated Polysiloxane Based Nanoparticles: a Prospective Randomized Phase II Clinical Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2019-03-26
Completion Date
2025-06-18
Last Updated
2026-09-15
Healthy Volunteers
No
Conditions
Interventions
AGuIX®
3 intravenous injection at 100mg/kg * D0: AGuIX® injection followed by MRI (within 7 days before commencement of WBRT) * Fr1: AGuIX® injection before the first radiation session * Fr6: AGuIX® injection before the sixth radiation session
Whole Brain Radiation Therapy
30 Gy in 10 fractions of 3 Gy over 2-3 weeks
Locations (14)
Hospices Civils de Lyon-Hôpital Lyon Sud
Lyon, France, France
Institut Curie Saint Cloud
Saint-Cloud, France, France
Institut Régional du Cancer
Montpellier, Occitanie, France
Institut Claudius Regaud Institut Universitaire du Cancer Toulouse Oncopole Radiothérapie
Toulouse, Occitanie, France
Centre Leon Berard Lyon
Lyon, Rhones Alpes, France
Centre Hospitalier Annecy Genevois
Annecy, Rhones-Alpes, France
Centre Hospitalier Universitaire Grenoble-Alpes
Grenoble, Rhones-Alpes, France
CRLCC - Institut Bergonié
Bordeaux, France
Crlcc Francois Baclesse
Caen, France
Centre Georges François Leclerc
Dijon, France
Hôpital Européen Georges Pompidou
Paris, France
La Pitié Salpêtrière - Charles Foix
Paris, France
Crlcc Paul Strauss
Strasbourg, France
Institut de Cancérologie de Lorraine ALEXIS VAUTRIN
Vandœuvre-lès-Nancy, France