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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT04899908
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic Radiation — RADIATION
    Focused radiation beams to treat tumors
  • AGuIX gadolinium-based nanoparticles — DRUG
    Intravenous injection
  • Placebo — OTHER
    Intravenous infusion

Study Details

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.

Key Dates

Start date
Sep 15, 2021
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
May 31, 2029

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Ayal Aizer
[email protected]
617-732-7560
Ayal Aizer, MD, MHS (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Ayal Aizer, MD, MPH
[email protected]
617-732-7560
Ayal Aizer, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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