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

  • STATUS
    Recruiting
  • End date
    Feb 27, 2026
  • participants needed
    112
  • sponsor
    Dana-Farber Cancer Institute
Updated on 27 October 2021
cancer
measurable disease
x-rays
metastasis
HER2
brain metastases
erbb2
her2/neu-positive breast cancer

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.

Description

This research study is a double-blind, randomized phase II clinical trial of brain-directed stereotactic radiation with or without AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles in the management of brain metastases at higher-risk of local recurrence with radiation alone.

The study agent (AGuIX gadolinium-based nanoparticles) has two main parts. The first is gadolinium, also known as "contrast," which is typically injected into a vein during a MRI scan. The second part is a nanoparticle (linked to the gadolinium) that may make focused radiation work more effectively. The AGuIX gadolinium-based nanoparticles are deposited within the brain metastases via the bloodstream and then the brain metastases are radiated.

The U.S. Food and Drug Administration (FDA) has not approved AGuIX gadolinium-based nanoparticles as a treatment for any disease. AGuIX gadolinium-based nanoparticles have been tested in other studies for safety and efficacy in patients with brain metastases who are also receiving radiation.

This study seeks to determine whether AGuIX gadolinium-based nanoparticles improve outcomes relative to placebo.Participants will be "randomized" into one of the study groups:

  • Group A: Radiation plus AGuIX gadolinium-based nanoparticles
  • Group B: Radiation plus placebo

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

NH TherAguix, the manufacturer of the AGuIX gadolinium-based nanoparticles, is supporting this research study by providing the AGuIX gadolinium-based nanoparticles that will be evaluated in this study.

NH TherAguix is also covering the cost of the study.

It is expected that about 112 people will take part in this research study.

Details
Condition Colorectal Cancer, gastrointestinal cancer, Cyst, Neoplasm of unspecified nature of digestive system, Whole Brain Radiation, Russell-Silver syndrome, Brain Metastasis, Digestive System Neoplasms, skin cancer, her2-positive breast cancer, GASTROINTESTINAL DISORDER, octreotide scan, Noncancerous Growth, HER2 Positive Breast Cancer, Lung Cancer, her2/neu-positive breast cancer, Bronchial Neoplasm, colorectal cancers, stereotactic radiation, Breast Cancer, melanoma, gastrointestinal cancers, Malignant neoplasm of brain, cancer, colorectal, tumors, colorectal, Lung Disease, Brain Metastases, SRT, Melanoma, Brain Tumor (Pediatric), Metastatic Melanoma, Malignant Melanoma, Breast Cancer Diagnosis, colorectal tumor, Gastrointestinal Neoplasm, colorectal neoplasm, breast carcinoma, Pulmonary Disease, Brain Tumor, Lung Neoplasm, Rectal disorder, Gastrointestinal Diseases and Disorders, nanoparticle, cancer, breast, Brain Cancer, Colon Cancer Screening, carcinoma lung, Colon cancer; rectal cancer, Rectal Disorders, Skin Cancer, somatostatin receptor scintigraphy, brain tumors, malignant brain tumor, lung carcinoma, aguix-np
Treatment Placebo, Stereotactic Radiation, AGuIX gadolinium-based nanoparticles
Clinical Study IdentifierNCT04899908
SponsorDana-Farber Cancer Institute
Last Modified on27 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning 5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial
disease
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
Metastases 2cm in maximal unidimensional size
Locally recurrent metastases after prior stereotactic radiation
Locally recurrent metastases after prior whole brain radiation Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases 2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation can only be treated in the strata permitting prior radiation (last two strata above)
Age 18 years at diagnosis of brain metastases
Estimated glomerular filtration rate of 60 mL/min/1.73m2
Karnofsky performance status of at least 70 (i.e. at minimum, "cares for self" but "unable to carry on normal activity or do active work")
Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and/or study PI
Ability to understand and the willingness to sign a written informed consent document
The effects of AGuIX on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the therapeutic component of study participation

Exclusion Criteria

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 nave 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
Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study
In cohorts who have received prior brain-directed radiation, patients are not eligible for this study if they have active (at the time of protocol screening) brain metastases that require radiation that are in or within 1.0cm of the brainstem, eyes, optic nerves, or optic chiasm if the juxtaposed organ at risk (i.e. brainstem, eyes, optic nerves, or optic chiasm) has previously received either >6.0 Gy in a single fraction or, if prior radiation was fractionated, a cumulative dose in 2.0 Gy equivalents, using an alpha/beta ratio of 2, of >40.0 Gy. In addition, all patients who have had prior brain-directed radiation, regardless of technique/dose/fractionation, are not eligible for the study until written approval is provided by the study/site PI
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