Radiotherapy of Multiple Brain Metastases Using AGuIX®
Key facts
- Who runs it
- University Hospital, Grenoble
- Where
- France14 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 106 people enrolled
- Started
- 26 Mar 2019
- Ended
- 18 Jun 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- AGuIX®
- Whole Brain Radiation Therapy
- Record updated
- 15 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous cranial irradiation (except stereotactic irradiation)
- Evidence of metastasis with recent large hemorrhage
- Progressive and threatening extracranial disease under systemic treatment
- Known contra-indication, sensitivity or allergy to gadolinium
- Renal insufficiency (glomerular filtration rate ≤ 50 mL/min/1.73m²)
- Leptomeningeal metastasis
- Known contra-indication for Magnetic Resonance Imaging
- Pregnancy or breastfeeding
- Subject under administrative or judicial control
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT).
Read full original descriptionShow less
The main endpoint will be evaluated by a blinded endpoint committee.
The 2 groups in the trial
- AGuIX® + Whole Brain Radiation TherapyTreatment being tested
Intervention: Drug: AGuIX® + WBRT Other Names: Gadolinium-chelated polysiloxane based nanoparticles 3 intravenous injections at 100mg/kg * D0: AGuIX® injection followed by MRI (within 7 days before commencement of WBRT) * Fr1: AGuIX® injection before the first radiation session * Fr6: AGuIX® injection before the sixth radiation session 30 Gy in 10 fractions of 3 Gy over 2-3 weeks
Treatment: AGuIX® and Whole Brain Radiation Therapy
- Whole Brain Radiation TherapyExisting treatment, for comparison
Intervention: Radiation: Whole Brain Radiation Therapy ( WBRT) 30 Gy in 10 fractions of 3 Gy over 2-3 weeks
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Radiotherapy of Multiple Brain Metastases Using AGuIX® Gadolinium-chelated Polysiloxane Based Nanoparticles: a Prospective Randomized Phase II Clinical Trial.
- Record updated
- 15 September 2026