Radiotherapy of multiple brain metastases using AGuIX® gadolinium-chelated polysiloxane based nanoparticles: a prospective randomized phase II clinical trial.

Radiotherapy of multiple brain metastases using AGuIX® gadolinium-chelated polysiloxane based nanoparticles: a prospective randomized phase II clinical trial. - NANORAD2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001879-20-FR

Enrollment

100

Registered

2018-05-29

Start date

2018-07-30

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with brain metastases, from a histologically confirmed solid tumor, eligible for WBRT MedDRA version: 20.0 Level: LLT Classification code 10006128 Term: Brain metastases System Organ Class: 100000004864

Interventions

Product Name: AGuIX Pharmaceutical Form: Lyophilisate for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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) performans 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 - No renal insufficiency (glomerular filtration rate = 50 mL/min/1.73m²) - Affiliated to a social security regimen - Effective methods of contraception must be used throughout the study . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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 - Inclusion in another clinical trial protocol - Pregnancy or breastfeeding - Subject in exclusion period of another study - Subject under administrative or judicial control

Design outcomes

Primary

Measure	Time frame
Main Objective: The Objective Intracranial Response is defined as having intracranial Complete Response (CR) or intracranial Partial Response (PR) for brain metastasis, assessed by contrast-enhanced MRI using RECIST v1.1 criteria. ;Secondary Objective: -Quality of life test (EORTC QLQ C30 and EORTC QLQ BN20) -Neurocognitive test (MoCA) - Evaluation of brain metastases response on Per protocol population, according to RECIST v1.1 criteria (or modified RECIST), by MRI at 6 weeks and 3 months, with MRI centralized reading on Per protocol -Evaluation of brain metastases response, according to RANO, to RECIST v1.1 criteria, and as the evolution of the sum of longest diameters (for all metastases with a sum of diameters > 1cm), by MRI at 6 weeks and 3, 6, 9 and 12 months -Evaluation of individual brain metastasis response, for all metastases with the sum of diameters > 1cm, by MRI rate at 6 weeks and 3, 6, 9 and 12 months -Death related to brain metastases progression -Death -Reporting of daily steroid dose -MRI evaluation of contrast enhancement at D0 after AGuIX® injection -Reporting of adverse events by type, frequency and severity for both treatments (WBRT and AGuIX® + WBRT).;Primary end point(s): Evaluation of brain metastases response, according to RECIST v1.1 criteria (or modified RECIST), by MRI at 6 weeks and 3 months, with MRI centralized reading;Timepoint(s) of evaluation of this end point: 6 weeks and 3 months	—

Measure

Time frame

Main Objective: The Objective Intracranial Response is defined as having intracranial Complete Response (CR) or intracranial Partial Response (PR) for brain metastasis, assessed by contrast-enhanced MRI using RECIST v1.1 criteria. ;Secondary Objective: -Quality of life test (EORTC QLQ C30 and EORTC QLQ BN20) -Neurocognitive test (MoCA) - Evaluation of brain metastases response on Per protocol population, according to RECIST v1.1 criteria (or modified RECIST), by MRI at 6 weeks and 3 months, with MRI centralized reading on Per protocol -Evaluation of brain metastases response, according to RANO, to RECIST v1.1 criteria, and as the evolution of the sum of longest diameters (for all metastases with a sum of diameters > 1cm), by MRI at 6 weeks and 3, 6, 9 and 12 months -Evaluation of individual brain metastasis response, for all metastases with the sum of diameters > 1cm, by MRI rate at 6 weeks and 3, 6, 9 and 12 months -Death related to brain metastases progression -Death -Reporting of daily steroid dose -MRI evaluation of contrast enhancement at D0 after AGuIX® injection -Reporting of adverse events by type, frequency and severity for both treatments (WBRT and AGuIX® + WBRT).;Primary end point(s): Evaluation of brain metastases response, according to RECIST v1.1 criteria (or modified RECIST), by MRI at 6 weeks and 3 months, with MRI centralized reading;Timepoint(s) of evaluation of this end point: 6 weeks and 3 months

—

Secondary

Measure	Time frame
Secondary end point(s): - Quality of life test (EORTC QLQ C30 and EORTC QLQ BN20) - Neurocognitive test (MoCA) - Evaluation of brain metastases response on Per protocol population, according to RECIST v1.1 criteria (or modified RECIST), by MRI at 6 weeks and 3 months, with MRI centralized reading on Per protocol - Evaluation of brain metastases response, according to RANO, to RECIST v1.1 criteria, and as the evolution of the sum of longest diameters (for all metastases with a sum of diameters > 1cm), by MRI at 6 weeks and 3, 6, 9 and 12 months - Evaluation of individual brain metastasis response, for all metastases with the sum of diameters > 1cm, by MRI rate at 6 weeks and 3, 6, 9 and 12 months - Death related to brain metastases progression - Death - Reporting of daily steroid dose - MRI evaluation of contrast enhancement at D0 after AGuIX® injection - Reporting of adverse events by type, frequency and severity for both treatments (WBRT and AGuIX® + WBRT).;Timepoint(s) of evaluation of this end point: 6 weeks, 3, 6, 9 and 12 months	—

Measure

Time frame

Secondary end point(s): - Quality of life test (EORTC QLQ C30 and EORTC QLQ BN20) - Neurocognitive test (MoCA) - Evaluation of brain metastases response on Per protocol population, according to RECIST v1.1 criteria (or modified RECIST), by MRI at 6 weeks and 3 months, with MRI centralized reading on Per protocol - Evaluation of brain metastases response, according to RANO, to RECIST v1.1 criteria, and as the evolution of the sum of longest diameters (for all metastases with a sum of diameters > 1cm), by MRI at 6 weeks and 3, 6, 9 and 12 months - Evaluation of individual brain metastasis response, for all metastases with the sum of diameters > 1cm, by MRI rate at 6 weeks and 3, 6, 9 and 12 months - Death related to brain metastases progression - Death - Reporting of daily steroid dose - MRI evaluation of contrast enhancement at D0 after AGuIX® injection - Reporting of adverse events by type, frequency and severity for both treatments (WBRT and AGuIX® + WBRT).;Timepoint(s) of evaluation of this end point: 6 weeks, 3, 6, 9 and 12 months

—

Countries

France

Contacts

Public ContactAdolle Anaïs

Grenoble Alps University Hospital

AAdolle@chu-grenoble.fr33(0)476 76 68 13

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026