RECRUITING

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

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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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone

Quick Facts

Study Start:2021-09-15

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04899908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Ayal Aizer, MD, MHS

CONTACT

(617) 732-7560

aaaizer@partners.org

Ivy Ricca, BA

CONTACT

6175828927

iricca@mgb.org

Principal Investigator

Ayal Aizer, MD, MHS

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-15

Study Completion Date2026-02

Study Record Updates

Study Start Date2021-09-15

Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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