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Stereotactic Radiation with or without AGuIX Nanoparticles for Brain Metastases

This study is testing if AGuIX gadolinium-based nanoparticles can make focused radiation (stereotactic radiation) work better for brain tumors that have spread from other cancers (brain metastases). These nanoparticles contain gadolinium, a substance often used in MRI scans, and are designed to help radiation target tumors more effectively. You may be eligible if you are 18 or older, have a confirmed solid cancer with at least one brain metastasis measuring 5mm or more, and meet specific criteria related to your primary cancer type, such as melanoma. The study aims to see if AGuIX nanoparticles reduce the chance of these tumors growing back locally within 6 months. The AGuIX nanoparticles are not yet approved by the FDA for any treatment.

Study design
This is a double-blind, randomized Phase II clinical trial involving 134 participants. Participants will receive either AGuIX gadolinium-based nanoparticles or a placebo, in addition to stereotactic radiation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, local recurrence, will be measured from enrollment to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04899908

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Brigham and Women's Hospital
~134 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:Stereotactic RadiationAGuIX gadolinium-based nanoparticlesPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local Recurrence
Measured over From enrollment to 6 months

Conditions

Brain Cancer
Brain Metastases
Melanoma
Lung Cancer
Breast Cancer
HER2-positive Breast Cancer
Colorectal Cancer
Gastrointestinal Cancer
SRS
SRT
Whole Brain Radiation
Stereotactic Radiation
AGuIX
Nanoparticle
Cystic
Brain Tumor

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NCT04899908

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ayal Aizer, MD, MHS · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Ayal Aizer, MD, MHS
[email protected]
(617) 732-7560
Email the study team

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Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • Local RecurrenceFrom enrollment to 6 months

    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.