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Tiny gadolinium particles aim to make brain radiation hit harder

NCT ID NCT03818386

Disease control Sponsor: University Hospital, Grenoble Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing whether adding AGuIX, a gadolinium-based nanoparticle, to whole brain radiation therapy improves how well brain metastases shrink in adults whose cancer has spread to the brain. Participants receive standard whole brain radiation, and some also receive three intravenous doses of AGuIX before and during radiation. The trial compares the two approaches and measures tumor response on MRI, along with quality of life and thinking tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AGuIX gadolinium-chelated polysiloxane nanoparticles
What this could lead to
If it works, this could offer a way to boost the effect of whole brain radiation for people whose cancer has spread to the brain, potentially improving tumor shrinkage without a new systemic drug.
What could go wrong
This is a phase 2 trial, so even a positive response rate would not prove the approach extends survival or works better than radiation alone. Nanoparticles given by injection carry unknown long-term risks, and the trial may not show a clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

106 people

The number who actually took part.

Started

Mar 2019

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with brain metastases, from a histologically confirmed solid tumor, eligible for WBRT * At least 18 years old * Signed informed consent after informing the patient * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * Extracranial disease: * Complete or partial response or stability under systemic treatment * No extracranial disease * Or first line of treatment * Life expectancy greater than 6 weeks * Effective contraceptive method for all patient of childbearing potential * Affiliated to a social security regimen Exclusion Criteria: * Leptomeningeal metastasis * Evidence of metastasis with recent large hemorrhage * Progressive and threatening extracranial disease under systemic treatment * Previous cranial irradiation (except stereotactic irradiation) * Known contra-indication, sensitivity or allergy to gadolinium * Known contra-indication for Magnetic Resonance Imaging * Renal insufficiency (glomerular filtration rate ≤ 50 mL/min/1.73m²) * Pregnancy or breastfeeding * Subject under administrative or judicial control

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Conditions

The condition(s) this trial relates to.

brain cancer metastatic malignant neoplasm in the brain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain metastases, adult Radiotherapy

Contacts and locations

Locations

  • CRLCC - Institut Bergonié

    Bordeaux, 33000, France

  • Centre Georges François Leclerc

    Dijon, 21079, France

  • Centre Hospitalier Annecy Genevois

    Annecy, Rhones-Alpes, 74374, France

  • Centre Hospitalier Universitaire Grenoble-Alpes

    Grenoble, Rhones-Alpes, 38700, France

  • Centre Leon Berard Lyon

    Lyon, Rhones Alpes, 69373, France

  • Crlcc Francois Baclesse

    Caen, 14000, France

  • Crlcc Paul Strauss

    Strasbourg, 67085, France

  • Hospices Civils de Lyon-Hôpital Lyon Sud

    Lyon, France, 69495, France

  • Hôpital Européen Georges Pompidou

    Paris, 75015, France

  • Institut Claudius Regaud Institut Universitaire du Cancer Toulouse Oncopole Radiothérapie

    Toulouse, Occitanie, 31059, France

  • Institut Curie Saint Cloud

    Saint-Cloud, France, 92210, France

  • Institut Régional du Cancer

    Montpellier, Occitanie, 34298, France

  • Institut de Cancérologie de Lorraine ALEXIS VAUTRIN

    Vandœuvre-lès-Nancy, 54519, France

  • La Pitié Salpêtrière - Charles Foix

    Paris, 75651, France

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