About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Stereotactic Radiation
  • AGuIX gadolinium-based nanoparticles
  • Placebo

Treatment groups

134 Participants
are divided into 2 treatment groups

Locations

2
Brigham and Women's Hospital02115, BostonMassachusetts, United States
Dana Farber Cancer Institute02115, BostonMassachusetts, United States

Sponsors and collaborators

Brigham and Women's Hospital

Lead sponsor

Dana-Farber Cancer Institute

Collaborator

TherAguix

Collaborator