Clinical trial · Interventional
Radiosensitization of Multiple Brain Metastases Using AGuIX Gadolinium Based Nanoparticles
Etude Clinique de Phase I de Radiosensibilisation de métastases cérébrales Par Nanoparticules de Gadolinium
NCT02820454CI-TRIAL-00038981NANO-RADcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. AGuIX particles may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation. PURPOSE: This first-in-man Phase I trial will study the side effects and best dose of AGuIX when injected together with whole brain radiation therapy in treating patients with multiple brain metastases. The effectiveness of the combination of AGuIX and radiation therapy will be also assessed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AGuIX | Drug | — | UNRESOLVED |
| whole brain radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AGuIX and radiotherapy
- description
- Patients receive a single intravenous injection of AGuIX on day 1. Then patients undergo a whole brain radiation therapy, 5 days a week in weeks 1-2. The first radiotherapy session will be performed 4 hours after AGuIX injection. Five dose escalation cohorts : 15 mg/kg, 30mg/kg, 50mg/kg, 75mg/kg and 100 mg/kg
- interventionNames
- Drug: AGuIX
- Radiation: whole brain radiation therapy
Primary outcomes (1)
- measure
- Maximum-tolerated dose (MTD) of polysiloxane gadolinium-chelates based nanoparticles (AGuIX) given concurrently to the whole brain radiation therapy for the treatment of multiple brain metastases
- timeFrame
- 18 months
- description
- To determine Maximum-tolerated dose (MTD) of polysiloxane gadolinium-chelates based nanoparticles (AGuIX) given concurrently to the whole brain radiation therapy, according to incidence of dose limiting toxicity (DLT) graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Patients with brain metastasis ineligible for local treatment by surgery or stereotactic radiation * At least 18 years old * Secondary brain metastases from a histologically confirmed solid tumor * Patient competent to give informed consent (ou Signed informed consent after informing the patient) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 * No prior brain irradiation * No renal insufficiency (glomerular filtration rate \> 60 mL/min/1.73m²) * Normal liver function (bilirubin \< 30 µmol/L; Alkaline phosphatase \< 400 UI/L; Aspartate aminotransferase (AST) \< 75 UI/L; Alanine aminotransferase (ALT) \< 175 UI/L) * For both male and female patients, effective methods of contraception must be used throughout the study. Acceptable methods of contraception are oral or implantable contraceptives, intrauterine device, condoms, spermicidal gels, or surgical sterilization. * Affiliated to a social security scheme or assimilated Exclusion criteria: * Meningeal carcinomatosis * Progressive and threatening extracranial disease * Previous cranial irradiation (whether whole or partial brain radiation therapy, except stereotactic irradiation) or total body irradiation * Known contra-indication, sensitivity or allergy to gadolinium * Patients unable to undergo or tolerate Magnetic Resonance Imaging * Patients participating in another clinical investigation at the time * Protected persons under articles L1121-5 to L1121-8, Code of Public Health
References
Publications (2)
- DERIVEDHuang S, Liu B, Peng F, Wang Y, Han S, Tu Y. Micro/Nanomotors Actively Penetrate Physiological Barriers: Basic Nanoarchitectonics to Practical Application. Adv Mater. 2026 Jan;38(6):e08865. doi: 10.1002/adma.202508865. Epub 2025 Aug 23. PMID 40847743
- DERIVEDVerry C, Sancey L, Dufort S, Le Duc G, Mendoza C, Lux F, Grand S, Arnaud J, Quesada JL, Villa J, Tillement O, Balosso J. Treatment of multiple brain metastases using gadolinium nanoparticles and radiotherapy: NANO-RAD, a phase I study protocol. BMJ Open. 2019 Feb 11;9(2):e023591. doi: 10.1136/bmjopen-2018-023591. PMID 30755445