The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.
Melanoma with intracranial growth consistent with tumor progression despite immunotherapy
Gastrointestinal primary
HER2 positive breast cancer (subtype assessed using most representative tissue available in opinion of enrolling clinician and/or study PI)
Cystic metastases
Participants who cannot undergo a brain MRI
Participants who cannot receive gadolinium
Participants with widespread, definitive leptomeningeal disease
Patients requiring radiation to either >10 targets (if naïve to whole brain radiation) or >20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and/or study PI
Parallel
Stereotactic Radiation
RadiationFocused radiation beams to treat tumors
AGuIX gadolinium-based nanoparticles
DrugIntravenous injection
Placebo
Other interventionIntravenous infusion
Local Recurrence
Assessed with Response Assessment in Neuro-Oncology (RANO) - Brain Metastasis Guidelines Time to local failure on a per metastasis basis will be performed using the log-rank test.
Overall Survival (OS)
Assessed with log-rank test
Progression-Free Survival (PFS)
Assessed with log-rank test
Time to Progression (TTP)
Assessed with log-rank test
Death due to neurologic causes
Assessed with Gray's test
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Brigham and Women's Hospital
Lead sponsor
Dana-Farber Cancer Institute
Collaborator
TherAguix
Collaborator
