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Brain Metastases, AdultPhase 2NANORAD2NCT03818386

Radiotherapy of Multiple Brain Metastases Using AGuIX®

A Phase 2 study testing AGuIX® and Whole Brain Radiation Therapy in people with Brain Metastases, Adult and Radiotherapy, run by University Hospital, Grenoble at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases, Adult, Radiotherapy
What is being tested?
AGuIX® and Whole Brain Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
14 sitesFrance
Study dates
26 Mar 2019to 18 Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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 join

  • 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
Show all 9Show fewer
  • Renal insufficiency (glomerular filtration rate ≤ 50 mL/min/1.73m²)
  • Pregnancy or breastfeeding
  • Subject under administrative or judicial control

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Centre Hospitalier Annecy Genevois

    Annecy, Rhones-Alpes, 74374

  • CRLCC - Institut Bergonié

    Bordeaux, 33000

  • Crlcc Francois Baclesse

    Caen, 14000

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Hospitalier Universitaire Grenoble-Alpes

    Grenoble, Rhones-Alpes, 38700

  • Hospices Civils de Lyon-Hôpital Lyon Sud

    Lyon, France, 69495

  • Centre Leon Berard Lyon

    Lyon, Rhones Alpes, 69373

  • Institut Régional du Cancer

    Montpellier, Occitanie, 34298

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • La Pitié Salpêtrière - Charles Foix

    Paris, 75651

  • Institut Curie Saint Cloud

    Saint-Cloud, France, 92210

  • Crlcc Paul Strauss

    Strasbourg, 67085

  • Institut Claudius Regaud Institut Universitaire du Cancer Toulouse Oncopole Radiothérapie

    Toulouse, Occitanie, 31059

  • Institut de Cancérologie de Lorraine ALEXIS VAUTRIN

    Vandœuvre-lès-Nancy, 54519

Other trials in France

About this study

Official title: Radiotherapy of Multiple Brain Metastases Using AGuIX® Gadolinium-chelated Polysiloxane Based Nanoparticles: a Prospective Randomized Phase II Clinical Trial.

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.

Read the detailed description

The occurrence of brain metastases is a common event in the history of cancer and negatively affects the life expectancy of patients. Their incidence varies between 15 and 50% according to the histologic types. Surgery, stereotactic radiosurgery, radiotherapy and chemotherapy are the main treatments currently proposed.

For patients with multiple brain metastases, whole brain radiation therapy (WBRT) remains the standard of care. However, the median overall survival is less than 6 months and new approaches need to be developed to improve treatment of these patients.

In this context, the weak control of the disease comes from three main factors: the multiplicity of the brain lesions, the radioresistance of certain histologies and the poor distribution of cytotoxic agents in brain metastases.

The use of radiosensitizing agents is here of great interest. The radiosensitizing agent chosen in this study is AGuIX®. It is a Gadolinium-chelated polysiloxane based nanoparticle developed by NH TherAguix company for its theranostic properties (radiosensitization and diagnosis by multimodal imaging). Preclinical studies have demonstrated the radiosensitizing effect of AGuIX® in vivo in 8 tumor models xenografted in rodents, and particularly in brain tumors.

Being tested
AGuIX®, Whole Brain Radiation Therapy
Keywords
gadolinium nanoparticles, AGuIX
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGuIX®Drug

    Also called Gadolinium-chelated polysiloxane based nanoparticles

    3 intravenous injection 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

  • Whole Brain Radiation TherapyRadiation

    Also called WBRT

    30 Gy in 10 fractions of 3 Gy over 2-3 weeks

Study groups in NCT03818386
Study groupRoleWhat they receive
AGuIX® + Whole Brain Radiation TherapyExperimentalIntervention: 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
Receives: Drug: AGuIX®; Radiation: Whole Brain Radiation Therapy
Whole Brain Radiation TherapyActive comparatorIntervention: Radiation: Whole Brain Radiation Therapy ( WBRT) 30 Gy in 10 fractions of 3 Gy over 2-3 weeks
Receives: Radiation: Whole Brain Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best objective intracranial response rate - intent-to-treat

    Evaluation of brain metastases response, according to RECIST v1.1 criteria (or modified RECIST) by MRI, with MRI centralized reading

    Measured: at 6 weeks

  2. Best objective intracranial response rate - intent-to-treat

    Evaluation of brain metastases response, according to RECIST v1.1 criteria (or modified RECIST) by MRI, with MRI centralized reading

    Measured: at 3 months

Secondary outcomes (12)

  1. Evaluation of the quality of life

    Quality of life test score EORTC QLQ C30

    Measured: at D0, 6 weeks, 3, 6, 9, 12 months

  2. Evaluation of the quality of life

    Quality of life test score EORTC QLQ BN20

    Measured: at day 0, 6 weeks, 3, 6, 9, 12 months

  3. Neurocognitive evaluation

    Neurocognitive test (MoCA)

    Measured: at Day 0, 6 weeks, 3, 6, 9, 12 months

  4. Best objective intracranial response rate - per-protocol

    Evaluation of brain metastases response on per-protocol population, according to RECIST v1.1 criteria (or modified RECIST), by MRI with centralized reading

    Measured: at 6 weeks and 3 months

  5. Evaluation of the intracranial response rate

    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

    Measured: for 12 months

  6. Evaluation of individual metastasis response

    Evaluation of individual brain metastasis response, for all metastases with the sum of diameters > 1cm, by MRI rate

    Measured: at 6 weeks and 3, 6, 9 and 12 months

  7. Intracranial progression-free survival

    Evaluation of the time between the start of the treatment and the occurence of intracranial progression or neuriologic death

    Measured: at 12 months

  8. Intracranial progression-free survival, brain survival

    Death related to brain metastases progression

    Measured: at 12 months

  9. Overall survival

    Death

    Measured: at 12 months

  10. Change in steroid dependence

    Reporting of daily steroid dose

    Measured: at 6 weeks and 3, 6, 9 and 12 months

  11. Incidence of adverse events

    Reporting of adverse events by type, frequency and severity for both treatments (WBRT and AGuIX® + WBRT)

    Measured: at 6 weeks and 3, 6, 9 and 12 months

  12. MRI study of the distribution of the product in brain metastases

    MRI evaluation of contrast enhancement at D0 after AGuIX® injection

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2019
  2. Study start26 Mar 2019
  3. Primary completion30 Sep 2024
  4. Study completion18 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective Randomized Open Blinded Endpoint phase II clinical trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03818386
Sponsor's protocol ID
38RC18.085
Acronym
NANORAD2
Status last verified
Sep 2026
First submitted
11 Dec 2018
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The provision of patient-level individualized databases (= pseudonymized data) may only be carried out within an appropriate regulatory and contractual framework to ensure compliance with applicable regulations (including the GDPR). Consequently, the data cannot be made freely available; however, you may contact the sponsor (CHUGA) with any requests for access to the data using the following addresses: juristerecherche@chu-grenoble.fr, ArcPromoteur@chu-grenoble.fr, AccueilRecherche@chu-grenoble.fr . This allows to review requests to determine how to respond to them in full compliance with the law, particularly in accordance with regulations regarding the protection of personal data.

Publications

  • Le 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.

    PubMed 22040385

  • Lux 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.

    PubMed 30226413

  • Verry 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.

    PubMed 27529506

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AGuIX® and Whole Brain Radiation Therapy in people with Brain Metastases, Adult and Radiotherapy, run by University Hospital, Grenoble at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best objective intracranial response rate - intent-to-treat (time frame: at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03818386, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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