Clinical trial · Interventional
Radiotherapy of Multiple Brain Metastases Using AGuIX®
Radiotherapy of Multiple Brain Metastases Using AGuIX® Gadolinium-chelated Polysiloxane Based Nanoparticles: a Prospective Randomized Phase II Clinical Trial.
NCT03818386CI-TRIAL-00077951NANORAD2completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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). The main endpoint will be evaluated by a blinded endpoint committee.
Conditions
Conditions (2)
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, Adult | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AGuIX® | Drug | — | UNRESOLVED |
| Whole Brain Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AGuIX® + Whole Brain Radiation Therapy
- description
- 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
- interventionNames
- Drug: AGuIX®
- Radiation: Whole Brain Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Whole Brain Radiation Therapy
- description
- Intervention: Radiation: Whole Brain Radiation Therapy ( WBRT) 30 Gy in 10 fractions of 3 Gy over 2-3 weeks
- interventionNames
- Radiation: Whole Brain Radiation Therapy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDLe Duc G, Miladi I, Alric C, Mowat P, Brauer-Krisch E, Bouchet A, Khalil E, Billotey C, Janier M, Lux F, Epicier T, Perriat P, Roux S, Tillement O. Toward an image-guided microbeam radiation therapy using gadolinium-based nanoparticles. ACS Nano. 2011 Dec 27;5(12):9566-74. doi: 10.1021/nn202797h. Epub 2011 Nov 9. PMID 22040385
- BACKGROUNDLux F, Tran VL, Thomas E, Dufort S, Rossetti F, Martini M, Truillet C, Doussineau T, Bort G, Denat F, Boschetti F, Angelovski G, Detappe A, Cremillieux Y, Mignet N, Doan BT, Larrat B, Meriaux S, Barbier E, Roux S, Fries P, Muller A, Abadjian MC, Anderson C, Canet-Soulas E, Bouziotis P, Barberi-Heyob M, Frochot C, Verry C, Balosso J, Evans M, Sidi-Boumedine J, Janier M, Butterworth K, McMahon S, Prise K, Aloy MT, Ardail D, Rodriguez-Lafrasse C, Porcel E, Lacombe S, Berbeco R, Allouch A, Perfettini JL, Chargari C, Deutsch E, Le Duc G, Tillement O. AGuIX(R) from bench to bedside-Transfer of an ultrasmall theranostic gadolinium-based nanoparticle to clinical medicine. Br J Radiol. 2019 Jan;92(1093):20180365. doi: 10.1259/bjr.20180365. Epub 2018 Sep 18. PMID 30226413
- BACKGROUNDVerry C, Dufort S, Barbier EL, Montigon O, Peoc'h M, Chartier P, Lux F, Balosso J, Tillement O, Sancey L, Le Duc G. MRI-guided clinical 6-MV radiosensitization of glioma using a unique gadolinium-based nanoparticles injection. Nanomedicine (Lond). 2016 Sep;11(18):2405-17. doi: 10.2217/nnm-2016-0203. Epub 2016 Aug 16. PMID 27529506