RecruitingPhase 2NCT04899908

Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases

A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone


Sponsor

Dana-Farber Cancer Institute

Enrollment

134 participants

Start Date

Sep 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding tiny gadolinium nanoparticles (called AGuIX) to targeted brain radiation (stereotactic radiosurgery) improves outcomes for people with cancer that has spread to the brain. The nanoparticles are designed to make radiation more effective right where it's needed. **You may be eligible if...** - You have a solid cancer with at least one confirmed or suspected tumor that has spread to the brain - Your brain tumor is at least 5mm in size - You have one of the following: melanoma that progressed despite immunotherapy, a GI cancer, HER2-positive breast cancer, cystic brain metastases, a large brain tumor (at least 2cm), or a tumor that has come back after prior brain radiation - You are 18 or older **You may NOT be eligible if...** - You have widespread cancer spreading rapidly in the brain - You have had allergic reactions to gadolinium contrast agents - Your overall health status is too poor to tolerate the treatment - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Radiation

Focused radiation beams to treat tumors

DRUGAGuIX gadolinium-based nanoparticles

Intravenous injection

OTHERPlacebo

Intravenous infusion


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT04899908


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