Using nanoparticles to enhance radiation treatment for brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of AGuIX gadolinium-based nanoparticles in combination with stereotactic radiation therapy for patients with brain metastases. It is a double-blind, randomized phase II trial where participants are assigned to receive either radiation with AGuIX nanoparticles or radiation with a placebo. The nanoparticles are designed to improve the efficacy of radiation treatment by being deposited within the brain metastases via the bloodstream. The study aims to determine if this combination leads to better outcomes compared to radiation alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Ayal Aizer, MD, MHS — Brigham and Women's Hospital
• Study coordinator: Ayal Aizer, MD, MHS
• Email: aaaizer@partners.org
• Phone: (617) 732-7560

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Riluzole to Help Breast Cancer Survivors with Cognitive Issues

  This study is testing if the medication riluzole can help breast cancer survivors who are having trouble with thinking and memory feel better.

  Recruiting Phase 2 University of California, Irvine · Orange, California · NCT06580002

• Collecting tumor samples to improve cancer treatment matching

  This study is collecting tumor samples from patients with advanced cancer to see if analyzing their genes can help doctors find the best treatments for them.

  Recruiting at 2 sites University Health Network, Toronto · Hamilton, Ontario and 6 other locations · NCT02906943

• LRRC15-targeted PET imaging for more precise diagnosis and staging of pancreatic, breast, lung, sarcoma and head-and-neck cancers

  This project tests whether an LRRC15-targeted PET scan can better detect and stage LRRC15-expressing cancers and measures how the tracer behaves in healthy adults.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07552467

• High-precision detection of leftover cancer using a liquid-biopsy platform (SHERLOCK)

  This project will test whether sensitive blood and other fluid tests for circulating tumor DNA can find leftover cancer (minimal residual disease) in adults treated with curative intent for breast, lung, melanoma, gynecologic, or genitourinary cancers.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07524114

• Florida ASCENT Program

  This project will test whether combining the MyCarePulse EHR platform with ASCENT patient navigators helps adults with recent cancer diagnoses in Florida improve food security, diet quality, and confidence in healthy eating compared with standard care.

  Recruiting University of Florida · Gainesville, Florida · NCT07042243

• IDOV-Immune for advanced solid tumors

  This trial will try a single IV infusion of an engineered oncolytic vaccinia virus called IDOV-Immune in adults with advanced solid tumors that no longer respond to standard treatments.

  Recruiting at 5 sites Phase 1 ViroMissile, Inc. · St Louis, Missouri and 4 other locations · NCT06910657

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.