Recruiting
Phase 2

Radiation with Aguix

Sponsor:

Brigham and Women's Hospital

Code:

NCT04899908

Conditions

Brain Cancer

Brain Metastases

Melanoma

Lung Cancer

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Radiation

AGuIX gadolinium-based nanoparticles

Placebo

Study Details

Brief 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.

Conditions

Brain Cancer

Brain Metastases

Melanoma

Lung Cancer

Breast Cancer

Study ID

NCT04899908

Start date

Sep 15, 2021

Status verified date

Aug, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stereotactic Radiation plus AGuIX gadolinium-based nanoparticles

Randomly assigned participants will receive:

  • AGuIX gadolinium-based nanoparticles 3-5 days before radiation is initiated
  • AGuIX gadolinium-based up to 2x during radiation, depending on standard of care radiation treatment.

  • If standard of care radiation treatment involves only one day of radiation, participant will receive AGuIX gadolinium-based nanoparticles on the day of radiation.
  • If standard of care radiation treatment involves 5 or 6 days of radiation, participant will receive AGuIX gadolinium-based nanoparticles two-times (2x) in total, on the first and third day of radiation.

experimental: Stereotactic Radiation plus placebo

Randomly assigned participants will receive:

  • Placebo 3-5 days before radiation is initiated
  • Placebo up to 2x during radiation, depending on standard of care radiation treatment.

  • If standard of care radiation treatment involves only one day of radiation participant will receive Placebo on the day of radiation.
  • If standard of care radiation treatment involves 5 or 6 days of radiation participant will receive Placebo two-times (2x) in total, on the first and third day of radiation.

Interventions

Stereotactic Radiation

Focused radiation beams to treat tumors

AGuIX gadolinium-based nanoparticles

Intravenous injection

Placebo

Intravenous infusion

Primary outcome measure

  • Local Recurrence [ Time Frame: From enrollment to 6 months ]

Central Contacts and Locations

Central contacts

Ayal Aizer, MD, MHS

(617) 732-7560aaaizer@partners.org

Marciana F Johnson, MPH

6175828335mjohnson71@mgb.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ayal Aizer

617-732-7560aaaizer@partners.org

Principal Investigator:

Ayal Aizer, MD, MHS

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ayal Aizer, MD, MPH

617-732-7560aaaizer@partners.org

Principal Investigator:

Ayal Aizer, MD, MPH

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 9, 2026

Last verified

Aug, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-09-09.