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Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients (SONOKID)

Primary Purpose

Malignant Brain Tumor, Malignant Glioma, Embryonal Tumor

Status
Recruiting
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
SonoCloud® (9 transducers)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Brain Tumor focused on measuring Low intensity pulsed ultrasound (LIPU), Therapeutic ultrasound, Blood-brain barrier (BBB), Malignant brain tumor, Brain cancer, Carboplatin, Children, Adolescents

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient aged ≥ 5 years old and < 18 years old
  • patient able to receive sonications and perform MRI studies without sedation
  • diagnosis of supra-tentorial primary malignant brain tumor (e.g. malignant glioma, embryonal tumor including ATRT, ependymoma)
  • recurrence or progression of brain tumor after at least a first line of standard treatment (multifocal tumors and metastatic disease allowed)
  • indication of treatment with carboplatin, validated in multidisciplinary meeting
  • Karnofsky performance scale index (patients ≥ 16 years old) or Lansky performance status (patients < 16 years old) > 50% (a patient with a performance status score altered by a motor deficit due to tumor infiltration will be allowed to be included)
  • no threat of brain herniation or uncontrolled intracranial hypertension
  • corticosteroids treatment ≤ 1mg/kg/day
  • neutrophils > 1.5 x 109/L
  • platelets > 100 x 109/L
  • total bilirubin < 1.5x upper limit of normal, AST et ALT < 2.5x upper limit of normal
  • serum creatinin < 1.5x upper limit of normal for the age or creatinine clairance >70mL/min/1.73m2 (EDTA method or 24h urine)
  • coagulation parameters in the normal limits for age (fibrinogen, prothrombin time and activated clotting time)
  • no grade 2 or more toxicity depending on the NCI-CTCAE v5.0 criteria
  • no healed wound on the scalp
  • covered by health insurance
  • for patients of chilbearing age (15-17 years old) : a negative pregnancy test and an efficient method of birth control
  • written consent signed by the patient (if possible) and his parents or legal representatives.

Exclusion Criteria:

  • weight <10kg
  • significant intra-tumoral bleeding (hematoma) or ipsilateral subdural effusion
  • antineoplastic treatment other than carboplatin taken at the same time or stopped since less than:

    • 6 weeks for nitrosoureas
    • 1 month for temozolomide
    • 1 month for bevacizumab
    • 5 half-lives for tyrosin kinase inhibitors
    • 3 weeks for any other chemotherapy

for the first sonication session

  • radiotherapy during the last 6 weeks
  • any other cancer treated during the last 5 years
  • any other uncontrolled disease or active infection
  • any other co-morbidity that could compromise participation to the study (in the judgement of the clinical investigator)
  • any anatomical particularity (skull thickness, thin skin) that could compromise a safe implantation of the device and/or compromise the quality of the treatment (in the judgement of the clinical investigator)
  • implanted defibrillator/pacemaker, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip
  • any contraindication to general anesthesia
  • any contraindication to MRI or known allergy to gadolinium or other MRI contrast agent/
  • any contraindication to ultrasound contrast agent:

    • allergy to the active substance or any excipient
    • acute coronary syndrome or uncontrolled ischemic heart disease
    • chronic heart failure or history of acute heart failure or heart failure grade III or IV
    • treatment with dobutamine
    • severe pulmonary arterial hypertension
    • uncontrolled systemic hypertension
    • respiratory distress syndrome
  • carboplartin hypersensitivity
  • treatment with phenytoin or fosphenytoin
  • earlier vaccination with attenuated alive vaccine
  • diminished auditory acuity ≥ grade 3 on CTCAE classification
  • history of thermoregulation disorder
  • impossibility of a rigorous medical follow-up due to geographic, social or mental reasons
  • pregnant and lactating women
  • contemporaneous treatment by anticoagulant or platelet aggregation inhibiting drugs
  • contemporaneous treatment possibly toxic for the central nervous system. The following treatments are excluded if taken less than 5 half-lives before the ultrasound session (unknown toxicity in case of BBB disruption) :

    • benzodiazepine (or any sedative or hypnotique drug)
    • antihistamine
    • proconvulsant drugs
    • butyrophenone, phenothiazine, or any "conventional" antipsychotic drug
    • barbiturate
    • MAO inhibitor
    • anticholinergic
    • anticoagulant
  • any contemporaneous treatment that, in the judgement of the clinical investigator, could induce brain toxicity after BBB disruption

Sites / Locations

  • Institut CurieRecruiting
  • Service de neurochirugie Pédiatrique - Hôpital Necker- Enfants MaladesRecruiting
  • Institut Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SonoCloud®

Arm Description

SonoCloud® : dose escalation 6 cycles of sonication

Outcomes

Primary Outcome Measures

Dose limiting toxicity directly linked to US emissions by the SonoCloud-9® (3 transducers)
Clinical evaluation (neurological deficit, intracranial hypertension, epilepsy) during acoustic pressure dose escalation, after each sonication (48h)
Dose limiting toxicity directly linked to US emissions by the SonoCloud-9®(3 transducers)
Radiological evaluation (hemorrage, ischemia, brain swelling) during acoustic pressure dose escalation, after each sonication

Secondary Outcome Measures

BBB opening intensity with the SonoCloud® device
Grading of BBB disruption using the scale previously described (Carpentier et al 2016), after each sonication
Clinical efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Overall Survival (OS)
Clinical efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Overall Survival (OS)
Radiological efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Progression Free Survival (PFS) using RANO Criteria
Radiological efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Progression Free Survival (PFS) using RANO Criteria
Allergic adverse events related to ultrasound contrast agent SonoVue®
Allergic reactions (cutaneous eruption, oedema, respiratory failure) in relation to the use of the ultrasound contrast agent SonoVue® for BBB disruption in the pediatric population, during and after each sonication
Cardiac adverse events related to ultrasound contrast agent SonoVue®
Cardiac reactions (thoracic pain, cardiac failure, EKG modification) in relation with the use of the ultrasound contrast agent SonoVue® for BBB disruption in the pediatric population, during and after each sonication
Feasibility of the BBB disruption technique
Complications associated with the implantation of the SonoCloud® device : acute pain evaluation using VAS (Visual Analogue Scale) for patients >_ 7 years old or using behavioral pain scale EVENDOL for patients <7 years old, immediately after implantation
Feasibility of the BBB disruption technique
Complications associated with the implantation of the SonoCloud® device : acute pain evaluation using VAS (Visual Analogue Scale) for patients >_ 7 years old or using behavioral pain scale EVENDOL for patients <7 years old, at day 1 after implantation
Feasibility of the BBB disruption technique
Complications associated with the implantation of the SonoCloud® device : chronic pain evaluation using VAS (Visual Analogue Scale) for patients >_7 years old or using behavioral pain scale EVENDOL for patients <7 years old, monthly, before each new cycle of treatment
Feasibility of the BBB disruption technique
Complications associated with the implantation of the SonoCloud® device using radiological examination : device position and post-operative complication (hematoma), one day after implantation
Feasibility of the BBB disruption procedure
Assessment of complications associated with the sonications : pain evaluation using VAS (Visual Analogue Scale) for patients >_ 7 years old or using behavioral pain scale EVENDOL for patients <7 years old at needle connexion
Feasibility of the BBB disruption procedure
Complications associated with the implantation of the SonoCloud® device : pain evaluation using VAS (Visual Analogue Scale) for patients >_ 7 years old or using behavioral pain scale EVENDOL for patients <7 years old, during sonication
Skin complications relation to the BBB disruption procedure
Assessment of skin complications associated with sonications : eschar and/or infection, before each cycle of treatment
Feasibility of the BBB disruption procedure
Process evaluated by the surgeon: number of tests necessary for needle connexion to the device, at each sonication
Feasibility of the BBB disruption procedure
Process evaluated by the surgeon : duration from needle connexion to the end of sonication, at each sonication
Feasibility of the BBB disruption procedure
Process evaluated by the surgeon : duration for device implantation
Biodisponibility of the SonoCloud-9® device
Histological analysis of tissue around the device : thickness, inflammation, biocompatibility, at explantation
Assessment of SonoCLOUD- 9® device resistance
Physical analysis of the device, at explantation
DNA and tumor cells concentrations in blood and cerebrospinal fluid
Evaluation of the effect of BBB disruption with the SonoCloud-9® device on the circulation of tumoral components in the blood flow, at each cycle of treatment

Full Information

First Posted
February 9, 2022
Last Updated
October 13, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
CarThera, Gustave Roussy, Cancer Campus, Grand Paris, Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT05293197
Brief Title
Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients
Acronym
SONOKID
Official Title
Phase I Trial Assessing the Safety of the Repeated Ultrasound-induced Opening of the Blood-brain Barrier in Pediatric Patients With Refractory Supra-tentorial Malignant Brain Tumors Before Chemotherapy Administration
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
CarThera, Gustave Roussy, Cancer Campus, Grand Paris, Institut Curie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose : the aim of this study is to assess the feasibility and safety of ultrasound-induced opening of the blood-brain barrier (BBB) with the SonoCloud-9 implantable ultrasound device in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor treated with carboplatin. Study hypothesis : the blood-brain barrier can be transiently and safely opened with pulsed low intensity ultrasound immediately prior to intravenously delivered chemotherapy. The opening of the BBB with the SonoCloud-9 system will increase the tumor exposure to carboplatin and increase progression-free and overall survival in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor.
Detailed Description
Malignant brain tumors are the first cause of death by cancer in children and adolescents. The dismal prognosis of malignant brain tumors is partially due to the existence of the blood brain barrier (BBB), a physiological barrier that limits the penetration of almost all molecules from the blood stream to the brain, including antineoplastic drugs. It has been shown that the application of low intensity ultrasound on the brain in association with intravenous microbubbles leads to transient and safe opening of the BBB. Many preclinical studies have demonstrated that ultrasound-induced opening of the BBB increases the distribution of therapeutic molecules into the brain and allows tumor control and increases survival in animal models (mice, rabbits, pigs, primates). An innovative implantable ultrasound system, the SonoCloud device, has been developed in order to repeatedly open the BBB in synchronization with chemotherapy protocols. This intracranial and subcutaneous device is not visible and MRI compatible and allows repeatable and ambulatory treatments. Moreover, such a device allows the delivery of low intensity ultrasound in a controlled and reproductible manner. A phase I/IIa trial has confirmed the feasibility and safety of this technique in adult patients treated for recurrent glioblastoma with carboplatin-based chemotherapy. This study will assess the feasibility and safety of ultrasound-induced opening of the BBB with the SonoCloud device in pediatric patients treated with carboplatin chemotherapy for a recurrent supra-tentorial malignant brain tumor. The study will determine the maximum tolerated ultrasound acoustic pressure that can be used for BBB opening and the safety of the activation of 3, then 9 transducers with the SonoCloud-9® device. Patients will follow 6 months cycles of treatment. If the treatment is well tolerated, patients will be able to be treated for 6 more cycles. The magnitude and intensity of the BBB opening, its clinical (overall survival) and radiological (progression-free survival) efficacy will be assessed as secondary endpoints. Safety of the ultrasound contrast agent SonoVue will also be evaluated in this indication in the pediatric population. An ancillary study will assess circulating tumor DNA (ctDNA) concentrations in patients with recurrence of a supra-tentorial malignant brain tumor, at diagnosis and during repeated opening of the BBB. The study will assess the correlation between ctDNA concentrations and tumor evolution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Brain Tumor, Malignant Glioma, Embryonal Tumor
Keywords
Low intensity pulsed ultrasound (LIPU), Therapeutic ultrasound, Blood-brain barrier (BBB), Malignant brain tumor, Brain cancer, Carboplatin, Children, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SonoCloud®
Arm Type
Experimental
Arm Description
SonoCloud® : dose escalation 6 cycles of sonication
Intervention Type
Device
Intervention Name(s)
SonoCloud® (9 transducers)
Intervention Description
SonoCloud®, sonication: dose escalation 6 cycles of sonication
Primary Outcome Measure Information:
Title
Dose limiting toxicity directly linked to US emissions by the SonoCloud-9® (3 transducers)
Description
Clinical evaluation (neurological deficit, intracranial hypertension, epilepsy) during acoustic pressure dose escalation, after each sonication (48h)
Time Frame
Monthly up to 12 months
Title
Dose limiting toxicity directly linked to US emissions by the SonoCloud-9®(3 transducers)
Description
Radiological evaluation (hemorrage, ischemia, brain swelling) during acoustic pressure dose escalation, after each sonication
Time Frame
Monthly up to 12 months
Secondary Outcome Measure Information:
Title
BBB opening intensity with the SonoCloud® device
Description
Grading of BBB disruption using the scale previously described (Carpentier et al 2016), after each sonication
Time Frame
Monthly, up to 12 months
Title
Clinical efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Description
Overall Survival (OS)
Time Frame
Month 3
Title
Clinical efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Description
Overall Survival (OS)
Time Frame
Month 6
Title
Radiological efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Description
Progression Free Survival (PFS) using RANO Criteria
Time Frame
Month 3
Title
Radiological efficacy of BBB disruption by the SonoCloud® device in association with systemic chemotherapy
Description
Progression Free Survival (PFS) using RANO Criteria
Time Frame
Month 6
Title
Allergic adverse events related to ultrasound contrast agent SonoVue®
Description
Allergic reactions (cutaneous eruption, oedema, respiratory failure) in relation to the use of the ultrasound contrast agent SonoVue® for BBB disruption in the pediatric population, during and after each sonication
Time Frame
Monthly, up to 12 months
Title
Cardiac adverse events related to ultrasound contrast agent SonoVue®
Description
Cardiac reactions (thoracic pain, cardiac failure, EKG modification) in relation with the use of the ultrasound contrast agent SonoVue® for BBB disruption in the pediatric population, during and after each sonication
Time Frame
Monthly, up to 12 months
Title
Feasibility of the BBB disruption technique
Description
Complications associated with the implantation of the SonoCloud® device : acute pain evaluation using VAS (Visual Analogue Scale) for patients >_ 7 years old or using behavioral pain scale EVENDOL for patients <7 years old, immediately after implantation
Time Frame
Monthly, up to 12 months
Title
Feasibility of the BBB disruption technique
Description
Complications associated with the implantation of the SonoCloud® device : acute pain evaluation using VAS (Visual Analogue Scale) for patients >_ 7 years old or using behavioral pain scale EVENDOL for patients <7 years old, at day 1 after implantation
Time Frame
Monthly, up to 12 months
Title
Feasibility of the BBB disruption technique
Description
Complications associated with the implantation of the SonoCloud® device : chronic pain evaluation using VAS (Visual Analogue Scale) for patients >_7 years old or using behavioral pain scale EVENDOL for patients <7 years old, monthly, before each new cycle of treatment
Time Frame
Monthly, up to 12 months
Title
Feasibility of the BBB disruption technique
Description
Complications associated with the implantation of the SonoCloud® device using radiological examination : device position and post-operative complication (hematoma), one day after implantation
Time Frame
Day 1 after implantation
Title
Feasibility of the BBB disruption procedure
Description
Assessment of complications associated with the sonications : pain evaluation using VAS (Visual Analogue Scale) for patients >_ 7 years old or using behavioral pain scale EVENDOL for patients <7 years old at needle connexion
Time Frame
Monthly, up to 12 months
Title
Feasibility of the BBB disruption procedure
Description
Complications associated with the implantation of the SonoCloud® device : pain evaluation using VAS (Visual Analogue Scale) for patients >_ 7 years old or using behavioral pain scale EVENDOL for patients <7 years old, during sonication
Time Frame
Monthly, up to 12 months
Title
Skin complications relation to the BBB disruption procedure
Description
Assessment of skin complications associated with sonications : eschar and/or infection, before each cycle of treatment
Time Frame
Monthly, up to 12 months
Title
Feasibility of the BBB disruption procedure
Description
Process evaluated by the surgeon: number of tests necessary for needle connexion to the device, at each sonication
Time Frame
Monthly, up to 12 months
Title
Feasibility of the BBB disruption procedure
Description
Process evaluated by the surgeon : duration from needle connexion to the end of sonication, at each sonication
Time Frame
Monthly, up to 12 months
Title
Feasibility of the BBB disruption procedure
Description
Process evaluated by the surgeon : duration for device implantation
Time Frame
During surgery
Title
Biodisponibility of the SonoCloud-9® device
Description
Histological analysis of tissue around the device : thickness, inflammation, biocompatibility, at explantation
Time Frame
12 months
Title
Assessment of SonoCLOUD- 9® device resistance
Description
Physical analysis of the device, at explantation
Time Frame
12 months
Title
DNA and tumor cells concentrations in blood and cerebrospinal fluid
Description
Evaluation of the effect of BBB disruption with the SonoCloud-9® device on the circulation of tumoral components in the blood flow, at each cycle of treatment
Time Frame
Monthly, up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient aged ≥ 5 years old and < 18 years old patient able to receive sonications and perform MRI studies without sedation diagnosis of supra-tentorial primary malignant brain tumor (e.g. malignant glioma, embryonal tumor including ATRT, ependymoma) recurrence or progression of brain tumor after at least a first line of standard treatment (multifocal tumors and metastatic disease allowed) indication of treatment with carboplatin, validated in multidisciplinary meeting Karnofsky performance scale index (patients ≥ 16 years old) or Lansky performance status (patients < 16 years old) > 50% (a patient with a performance status score altered by a motor deficit due to tumor infiltration will be allowed to be included) no threat of brain herniation or uncontrolled intracranial hypertension corticosteroids treatment ≤ 1mg/kg/day neutrophils > 1.5 x 109/L platelets > 100 x 109/L total bilirubin < 1.5x upper limit of normal, AST et ALT < 2.5x upper limit of normal serum creatinin < 1.5x upper limit of normal for the age or creatinine clairance >70mL/min/1.73m2 (EDTA method or 24h urine) coagulation parameters in the normal limits for age (fibrinogen, prothrombin time and activated clotting time) no grade 2 or more toxicity depending on the NCI-CTCAE v5.0 criteria no healed wound on the scalp covered by health insurance for patients of chilbearing age (15-17 years old) : a negative pregnancy test and an efficient method of birth control written consent signed by the patient (if possible) and his parents or legal representatives. Exclusion Criteria: weight <15kg significant intra-tumoral bleeding (hematoma) or ipsilateral subdural effusion antineoplastic treatment other than carboplatin taken at the same time or stopped since less than: 6 weeks for nitrosoureas 1 month for temozolomide 1 month for bevacizumab 5 half-lives for tyrosin kinase inhibitors 3 weeks for any other chemotherapy for the first sonication session radiotherapy during the last 6 weeks any other cancer treated during the last 5 years any other uncontrolled disease or active infection any other co-morbidity that could compromise participation to the study (in the judgement of the clinical investigator) any anatomical particularity (skull thickness, thin skin) that could compromise a safe implantation of the device and/or compromise the quality of the treatment (in the judgement of the clinical investigator) implanted defibrillator/pacemaker, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip any contraindication to general anesthesia any contraindication to MRI or known allergy to gadolinium or other MRI contrast agent/ any contraindication to ultrasound contrast agent: allergy to the active substance or any excipient acute coronary syndrome or uncontrolled ischemic heart disease chronic heart failure or history of acute heart failure or heart failure grade III or IV treatment with dobutamine severe pulmonary arterial hypertension uncontrolled systemic hypertension respiratory distress syndrome carboplartin hypersensitivity treatment with phenytoin or fosphenytoin earlier vaccination with attenuated alive vaccine diminished auditory acuity ≥ grade 3 on CTCAE classification history of thermoregulation disorder impossibility of a rigorous medical follow-up due to geographic, social or mental reasons pregnant and lactating women contemporaneous treatment by anticoagulant or platelet aggregation inhibiting drugs contemporaneous treatment possibly toxic for the central nervous system. The following treatments are excluded if taken less than 5 half-lives before the ultrasound session (unknown toxicity in case of BBB disruption) : benzodiazepine (or any sedative or hypnotique drug) antihistamine proconvulsant drugs butyrophenone, phenothiazine, or any "conventional" antipsychotic drug barbiturate MAO inhibitor anticholinergic anticoagulant any contemporaneous treatment that, in the judgement of the clinical investigator, could induce brain toxicity after BBB disruption
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin BECCARIA, MD, PhD
Phone
+33 1 71 39 65 92
Email
kevin.beccaria@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nelly BRIAND, MD, PhD
Phone
+33 1 44 38 18 62
Email
nelly.briand@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin BECCARIA, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck BOURDEAUT, MD, PhD
Phone
+33 1 4432 44 71
Email
franck.bourdeaut@curie.fr
First Name & Middle Initial & Last Name & Degree
Franck BOURDEAUT
Facility Name
Service de neurochirugie Pédiatrique - Hôpital Necker- Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin BECCARIA, MD, PhD
Phone
+33 1 71 39 65 92
Email
kevin.beccaria@aphp.fr
First Name & Middle Initial & Last Name & Degree
Kevin BECCARIA
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques GRILL, MD, PhD
Phone
+33 142116209
Email
jacques.grill@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Jacques GRILL

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27306666
Citation
Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.
Results Reference
background
PubMed Identifier
30890548
Citation
Idbaih A, Canney M, Belin L, Desseaux C, Vignot A, Bouchoux G, Asquier N, Law-Ye B, Leclercq D, Bissery A, De Rycke Y, Trosch C, Capelle L, Sanson M, Hoang-Xuan K, Dehais C, Houillier C, Laigle-Donadey F, Mathon B, Andre A, Lafon C, Chapelon JY, Delattre JY, Carpentier A. Safety and Feasibility of Repeated and Transient Blood-Brain Barrier Disruption by Pulsed Ultrasound in Patients with Recurrent Glioblastoma. Clin Cancer Res. 2019 Jul 1;25(13):3793-3801. doi: 10.1158/1078-0432.CCR-18-3643. Epub 2019 Mar 19.
Results Reference
background
Links:
URL
http://carthera.eu/fr/
Description
more information about the SonoCloud® device and related clinical trials

Learn more about this trial

Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients

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