Study on Stereotactic Brain Radiation with or without AGuIX Gadolinium-Based Nanoparticles for Brain Metastases

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04899908

Provider View

This clinical trial is exploring whether adding AGuIX gadolinium-based nanoparticles to stereotactic brain radiation can improve treatment outcomes for patients with brain metastases that are difficult to control with radiation alone.

Patient Parameters

Program Overview

The aim of this study is to find out if AGuIX gadolinium-based nanoparticles can make radiation therapy more effective for treating brain metastases, which are cancer cells that have spread to the brain. These nanoparticles are designed to enhance the effects of radiation by being delivered to the brain tumors through the bloodstream. The study will compare the results of using radiation with these nanoparticles against using radiation with a placebo.

Description

This research is a double-blind, randomized phase II clinical trial, meaning neither the participants nor the researchers know who is receiving the nanoparticles or the placebo. The study involves using stereotactic radiation, a precise form of radiation therapy, with or without AGuIX gadolinium-based nanoparticles to treat brain metastases that are at a higher risk of returning after radiation alone.

AGuIX nanoparticles consist of gadolinium, a contrast agent used in MRI scans, linked to nanoparticles that may enhance the effectiveness of focused radiation. These nanoparticles are delivered to the brain metastases through the bloodstream, where they are then targeted with radiation.

The U.S. Food and Drug Administration (FDA) has not yet approved AGuIX gadolinium-based nanoparticles for treating any disease, but they have been tested in other studies for safety and effectiveness in patients with brain metastases receiving radiation.

Participants will be randomly assigned to one of two groups:

  • Group A: Receives radiation plus AGuIX gadolinium-based nanoparticles.
  • Group B: Receives radiation plus a placebo.

The study includes screening for eligibility, treatment, and follow-up visits. NH TherAguix, the company that makes the nanoparticles, is providing them for the study and covering the study costs. About 134 people are expected to participate.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed solid cancer and at least one brain tumor that is 5mm or larger, which is either consistent with or proven to be a brain metastasis.
    • Specific conditions include:
      • Melanoma with brain growth despite immunotherapy
      • Gastrointestinal cancer
      • HER2 positive breast cancer
      • Cystic metastases
      • Metastases 2cm or larger
      • Recurrence after previous brain radiation
  • Must be 18 years or older.
  • Must have good kidney function.
  • Must be able to care for themselves but may not be able to do normal activities or work.
  • Must have an expected survival of at least 3 months.
  • Must be able to understand and sign a consent form.
  • Women of childbearing potential must use effective contraception during the study.

Exclusion Criteria

  • Cannot undergo a brain MRI.
  • Cannot receive gadolinium.
  • Have widespread leptomeningeal disease.
  • Require radiation to more than 10 or 20 targets, depending on previous treatments.
  • Pregnant or breastfeeding women are not eligible.
  • Have active brain metastases near critical areas like the brainstem or eyes if they have received certain levels of previous radiation.

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