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Brain MetastasesPhase 1NANO-RADNCT02820454

Radiosensitization of Multiple Brain Metastases Using AGuIX Gadolinium Based Nanoparticles

A Phase 1 study testing AGuIX and whole brain radiation therapy in people with Brain Metastases, run by University Hospital, Grenoble at 1 site 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases
What is being tested?
AGuIX and whole brain radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteFrance
Study dates
Mar 2016to Feb 2019
Phase
Phase 1
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 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital Grenoble

    Grenoble, 38100

Other trials in France

About this study

Official title: Etude Clinique de Phase I de Radiosensibilisation de métastases cérébrales Par Nanoparticules de Gadolinium

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.

Read the detailed description

The present study will investigate the safety, tolerability and spectrum of side effects of AGuIX in combination with whole brain radiation therapy. As such, this study will characterize the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of in combination with whole brain radiation therapy in patients with multiple brain metastases.

On day 1, patients will receive a single intravenous injection of AGuIX. An MRI scan will be performed 2 hours after injection to visualize the distribution of AGuIX in brain metastases and surrounding healthy tissue, and to evaluate the contrast enhancement in brain metastases. Then patients will undergo a whole brain radiation therapy, starting 4 hours after AGuIX injection, up to completion of 2 weeks, 5 days a week of treatment (30Gy, 3Gy/fraction).

During the first 24h after injection, several blood draws will be also performed in order to assess the pharmacokinetic of AGuIX.

After completion of study treatment, patients will be followed periodically.

Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of AGuIX combined with whole brain radiation therapy. Three subjects will initially enter at each dose. If none of the three experiences a dose-limiting toxicity we will proceed to the next dose. If one of the three experiences that level of toxicity, we will accrue 3 more subjects at that dose. If at any time there are two or more dose-limiting toxicities (in the 3-6 subjects) on a given dose, we will drop down to a lower dose. Dose escalation will continue until the MTD of AGuIX and whole brain radiation therapy is established. The MTD will then be one dose below the DLT occurring in at least 1 out of 3 subjects (2 out of 6 patients).

Being tested
AGuIX, whole brain radiation therapy
Keywords
AGuIX, polysiloxane gadolinium-chelates based nanoparticles
Medical subject headings
Brain Neoplasms

What participants receive

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

  • AGuIXDrug

    Also called Nano-sized gadolinium particles

    A single intravenous injection on day 1. Dose level 1: 15mg/kg; Dose level 2: 30mg/kg, Dose level 3: 50mg/kg; Dose level 4: 75mg/kg; Dose level 5: 100mg/kg

  • whole brain radiation therapyRadiation

    30Gy in 10 sessions of 3Gy (5 days a week in weeks 1-2); first session 4 hours after AGuIX injection.

Study groups in NCT02820454
Study groupRoleWhat they receive
AGuIX and radiotherapyExperimentalPatients 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
Receives: Drug: AGuIX; Radiation: whole brain radiation therapy

What is being measured

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

  1. 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

    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

    Measured: 18 months

Secondary outcomes (6)

  1. Pharmacokinetic characteristics of AGuIX particles after intravenous injection

    Cmax

    Measured: 18 months

  2. Pharmacokinetic characteristics of AGuIX particles after intravenous injection

    AUC

    Measured: 18 months

  3. Pharmacokinetic characteristics of AGuIX particles after intravenous injection

    T1/2

    Measured: 18 months

  4. Distribution of AGuIX particles in brain metastases and surrounding healthy tissue evaluated by MRI

    Measure of the T1 contrast enhancement in brain metastases and surrounding healthy tissue after intravenous administration of AGuIX particles

    Measured: 30 months

  5. Intracranial progression-free survival

    The intracranial progression-free survival will be assessed by MRI (1,3, 6, 9 and 12 months from the date of discovery of the metastases)

    Measured: 12 months after radiation

  6. Overall survival

    The overall survival will be assessed starting from the date of discovery of the metastases

    Measured: 30 months

Timeline

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

  1. First posted1 Jul 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionFeb 2019
  4. Study completionFeb 2019

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02820454
Sponsor's protocol ID
38RC15.278
Other IDs
2015-004259-30, 2015
Acronym
NANO-RAD
Status last verified
Apr 2019
First submitted
2 Jun 2016
Last updated
7 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Huang 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.

    PubMed 40847743

  • Verry 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.

    PubMed 30755445

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AGuIX and whole brain radiation therapy in people with Brain Metastases, run by University Hospital, Grenoble at 1 site 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 10 inclusion and 7 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 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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 (time frame: 18 months). 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 NCT02820454, which also lists 2 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 7 Jun 2019.

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