NCT04899908
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
Recruiting
PHASE2Ages 18+InterventionalTreatmentBrigham and Women's HospitalInvestigator-initiated
~134 participants
Updated 2026-06-17 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
Where it's being run
2 sites across 1 statesMassachusetts2
Study leadership
- Ayal Aizer, MD, MHS · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
Who to contact
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Do you actually qualify for this trial?
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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.