search
Back to results

Innovative SonoCloud-9 Device for Blood Brain Barrier Opening in First Line Temozolomide Glioblastoma Patients. (SonoFIRST)

Primary Purpose

Initial Radiological Diagnosis Eligible for Tumor Resection, Initial Radiological Diagnosis Compatible With Newly Diagnosed Glioblastoma (IDH Wild-type), Eligible for the Standard of Care Including Concurrent Temoradiation and Adjuvant Temozolomide

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SonoCloud-9 (SC9) device
Temozolomide according Stupp protocol
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Initial Radiological Diagnosis Eligible for Tumor Resection focused on measuring Primary brain cancer, Glioblastoma, first line, Stupp protocol, Ultrasounds, Medical device, SC9

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria :

  1. Age ≥ 18 years , able and willing to give signed and informed consent. Inclusion for patients aged >70 years should be validated in neuro-oncology tumor board (RCP)
  2. MRI with suspicion of GBM or Patient with a newly histologically proven IDHwt GBM by previous stereotaxic biopsy or king size opened biopsy
  3. Karnofsky Performance Status ≥ 70
  4. Patient eligible for a total or sub-total surgical tumor resection
  5. Maximal tumor enhancement diameter at inclusion (pre surgery) ≤ 70 mm in T1W MRI
  6. Patient eligible after surgery for the first line standard of care temoradiation and adjuvant TMZ (Stupp protocol, 54)
  7. Patient with adequate organ and bone marrow function within 14 days prior to registration, as defined below:

    • Hemoglobin ≥ 10.0 g/dL
    • Leukocytes ≥ 3,000/L
    • Absolute neutrophil count ≥ 1,500/L
    • Platelets ≥ 100,000/L
    • Total bilirubin < 1.5 x ULN
    • AST(SGOT)/ALT(SPGT) ≤ 3 x institutional ULN
    • Alkaline phosphatase (ALP) < 3 x ULN
    • Normal creatine clearance ≥ 60 mL/minute.
    • Prothrombin time and partial thromboplastin time within institutional limits.
  8. For women of childbearing potential, a negative pregnancy test before inclusion and a medically acceptable method of birth control used throughout the study are required. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 1 month after the end of study visit
  9. A male patient must agree to use contraception as detailed in this Protocol during the treatment period and for at least 6 months after the last cycle of TMZ; he must refrain from donating sperm during this period
  10. Patient capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol
  11. Patient must be a beneficiary of or affiliated with a social security scheme

Exclusion Criteria :

  1. Patients with multifocal tumor (unless all localized in a 70 mm diameter area accessible to ultrasound field) or located in posterior fossa tumor
  2. Patient with diffuse FLAIR abnormalities attributable to Gliomatosis
  3. Patients with evidence of uncontrolled intracranial pressure
  4. Patients with uncontrolled epilepsy
  5. Patients with medical need to continue antiplatelet or antithrombotic treatment
  6. Pregnant or breastfeeding women (blood pregnancy test)
  7. Patients with contra-indications to MRI or known sensitivity/allergy to gadolinium, or other intravascular contrast agents
  8. Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Luminity®/Definity®
  9. Patients with known intracranial aneurism, with and/or unremovable coils, clips, shunts, intravascular stents, wafer, non resorbable dura substitute, or reservoirs
  10. Patients with an uncontrolled intercurrent illness or any pre-existing comorbidities that in the Investigator's opinion may prevent the implantation of the device or may impair the ability of the patient to receive treatment with SonoCloud or may be cofounding for evaluation of the clinical trial.
  11. Patients with the following are not eligible:

    • Known arterial hypertension grade 3 or higher without adequate control on medications
    • Known or suspected unstable active or chronic infections requiring systemic treatment
    • Known significant cardiac disease: right-to-left shunts, Unstable angina pectoris, Symptomatic congestive heart failure, Unstable cardiac arrhythmia
    • Known significant pulmonary disease: severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, adult respiratory distress syndrome, or Pneumonitis
    • Known Severe renal failure
    • Known serious myelosuppression
    • Known Psychiatric illness/social situations that would limit compliance with study requirements
    • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
    • Known immunodeficiency disease or treatments (HIV)
    • Known viral or bacterial chronic/acute disease (potential blood borne infections that could result in meningitis or brain abscess)
  12. Patients under judicial protection
  13. Patients with any following prohibited treatments:

    • Any investigational medicinal product within 30 days prior to inclusion and during the study
    • Antibiotics with known neurotoxicity (eg, aminoglycosides, cephalosporin, quinolones), unless substitution is not possible,
    • Non-absorbable material (dura matter substitute, hemostatic agent…)
    • Any other drug according investigator to cause cerebral toxicity due to BBB opening
    • Contra-indications to temozolomide
    • Dacarbazine hypersensitivity
  14. Implantation of the SC-9 not possible according to neurosurgeon (any patient morphological characteristics (e.g. skin thin thickness >9mm), which, from neurosurgeons' opinion, prevent implantation of the device or may impair the ability of the patient to receive treatment with SonoCloud, would be excluded)

Sites / Locations

  • Katholieke Universiteit LeuvenRecruiting
  • Centre hospitalier Universitaire d'AngersRecruiting
  • Groupe Hospitalier Saint-AndréRecruiting
  • Hospices Civils de Lyon, Hôpital Pierre WertheimerRecruiting
  • AP-HM, La Timone, Hôpital UniversitaireRecruiting
  • APHP-Sorbonne, Pitié Salpêtrière HospitalRecruiting
  • Centre hospitalier universitaire vaudois CHUV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ultrasound experimental arm

Control arm

Arm Description

Standard of Care + 15 Ultrasound BBB opening

Standard of Care

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS), PFS is defined as the time between randomization and disease progression which is the first documented tumor progression (per local Investigator assessment according to the RANO criteria) or death due to any cause.
Progression will be assessed by local investigator according to the RANO criteria

Secondary Outcome Measures

Overall Survival improvement (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
central review Progression Free Survival (crPFS)
The central review Progression Free Survival is evaluated by a central assessment (independent imaging core lab) at the end of study and is defined as the time between randomization and tumor progression which is the first documented tumor progression according to the radiological RANO criteria or death due to any cause
immune Progression Free Survival (iPFS)
The iPFS is evaluated according to iRANO (immune-related modifications / pseudo-progression ) criteria assessed by local investigator
Mean score of Patient quality of life preservation - EORTC Quality of Life Questionnaire C30
Quality of Life Questionnaire (QLQ) according to the European Organization for Research and Treatment of Cancer will be assessed by mean scores of the EORTC QLQ C-30 questionnaire (30 questions, score from 30 to 126) by local investigator or nurses and patient
Mean score Patient quality of life preservation - BN20 Quality of Life Questionnaire
Quality of Life Questionnaire (QLQ) according to the European Organization for Research and Treatment of Cancer will be assessed will be assessed by means of the EORTC BN20 questionnaire (30 questions, score from 1 to 80) by local investigator or nurses and patient
Karnofsky Performance Status (KPS)
Mean score of Patient cognitive preservation
Mini Mental Status Examination (30-point questionnaire, score from 1 to 30) mean score assessed by local investigator or nurses and patient
Visual analogic scale (VAS) Pain score from surgical area
pain score from surgical area using visual analogic scale (score 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible).
Esthetical
score in self-confidence concerning esthetical dimension of surgical scar using esthetical comfort question equivalent to q39 of QLQ-BR23 questionnaire: Does your skull scar induce any esthetic burden to you? Not at all A little Quite a bit Very much
Safety : Type, frequency and severity of adverse events and serious adverse events
Safety confirmation of efficient blood brain barrier opening procedure with the SonoCloud-9 system. Safety confirmation is assessed by the frequency and severity of Adverse Events (AE) (incidence of AE summarized by system organ class and/or preferred term and severity) based on the Common Terminology Criteria for Adverse Events, version 5.0.

Full Information

First Posted
October 21, 2020
Last Updated
March 28, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT04614493
Brief Title
Innovative SonoCloud-9 Device for Blood Brain Barrier Opening in First Line Temozolomide Glioblastoma Patients.
Acronym
SonoFIRST
Official Title
Multisite Open-label Randomized Phase II Clinical Trial in Newly Diagnosed Glioblastoma Treated by Concurrent Temoradiation and Adjuvant Temozolomide +/- Ultrasound-induced Blood Brain Barrier Opening.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

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
Glioblastoma (GBM) is an aggressive cancer with a progression-free survival (PFS) of 7 months and an overall survival (OS) of 15 months. Many therapeutic approaches have failed to improve the prognosis of patients to date. One of the main reasons is the presence of blood brain barrier (BBB) which limits therapeutic agents uptake in the brain. GBM is also considered to have a "cold" (unresponsive) immunological microenvironment due to factors released by the tumor and the presence of BBB limiting the transit of immune cells from the systemic circulation. Therefore, by-passing the BBB appears as a promising strategy. The objective of the Phase II clinical trial, SonoFIRST, is to evaluate if the use of therapeutic ultrasound device, sonoCloud-9 (SC9) could improve the progression free survival of newly diagnosed GBM patients, treated by concurrent temoradiation and adjuvant temozolomide. The transient opening of the BBB by ultrasound with the SonoCloud-9 (SC9) device, predicts the increase in the penetration of temozolomide (TMZ) into the brain and the stimulation of cerebral immunity with the prospect of improving the survival of 160,000 new brain tumor patients each year in Europe and the United States.
Detailed Description
This will be an open-label, Phase 2, multicenter, double arm, randomized, interventional trial that will evaluate primarily the clinical efficacy of the device and will be to compare Progression Free Survival (PFS) between the standard of care treatment with concomitant ultrasound BBB opening versus standard of care alone. Glioblastoma (GBM) is the most common and aggressive primary brain cancer. Currently, prognosis is very poor, with a survival of about 15 months with current therapies. Although intensive treatments combining surgery, radiotherapy and chemotherapy, the prognosis of GBM patients remains poor. New treatment strategies are urgently needed. In the brain, the presence of the blood-brain barrier (BBB) limits the uptake of therapeutic agents. To encounter this BBB issue, Professor Alexandre Carpentier and his team developed an ultrasound medical device (SonoCloud), implanted in the skull during surgery. This highly innovative technique temporarily permeates the BBB, increasing drug delivery to the brain by five times. The SonoCloud, a low-intensity pulsed ultrasound device developed by CarThera, is one of the major innovations in this field, as shown by the encouraging results obtained in studies in recurrent GBM. The expected benefits of using the SonoCloud-9 experimental device prior to TMZ chemotherapy are the stabilization or reduction of GBM tumor volume on the one hand, and stabilization or improvement of the patient's neurological status on the other hand. Participation in the clinical trial will contribute to a better understanding of the safety and efficacy of opening the BBB. It will be possible to determine whether the BBB opening using low-intensity pulsed ultrasound can be effective in treating GBM, in addition to the standard of care protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Initial Radiological Diagnosis Eligible for Tumor Resection, Initial Radiological Diagnosis Compatible With Newly Diagnosed Glioblastoma (IDH Wild-type), Eligible for the Standard of Care Including Concurrent Temoradiation and Adjuvant Temozolomide
Keywords
Primary brain cancer, Glioblastoma, first line, Stupp protocol, Ultrasounds, Medical device, SC9

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound experimental arm
Arm Type
Experimental
Arm Description
Standard of Care + 15 Ultrasound BBB opening
Arm Title
Control arm
Arm Type
Other
Arm Description
Standard of Care
Intervention Type
Device
Intervention Name(s)
SonoCloud-9 (SC9) device
Intervention Description
daily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months) with 6 concomitant Blood Brain Barrier opening sessions by ultrasound + 9 Blood Brain Barrier opening sessions by ultrasound without any associated drug
Intervention Type
Drug
Intervention Name(s)
Temozolomide according Stupp protocol
Intervention Description
daily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months)
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS), PFS is defined as the time between randomization and disease progression which is the first documented tumor progression (per local Investigator assessment according to the RANO criteria) or death due to any cause.
Description
Progression will be assessed by local investigator according to the RANO criteria
Time Frame
Between randomisation and 18 months after the last inclusion.
Secondary Outcome Measure Information:
Title
Overall Survival improvement (OS)
Description
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time Frame
Between randomisation and 18 months after the last inclusion.
Title
central review Progression Free Survival (crPFS)
Description
The central review Progression Free Survival is evaluated by a central assessment (independent imaging core lab) at the end of study and is defined as the time between randomization and tumor progression which is the first documented tumor progression according to the radiological RANO criteria or death due to any cause
Time Frame
Between randomisation and 18 months after the last inclusion.
Title
immune Progression Free Survival (iPFS)
Description
The iPFS is evaluated according to iRANO (immune-related modifications / pseudo-progression ) criteria assessed by local investigator
Time Frame
Between randomisation and 18 months after the last inclusion.
Title
Mean score of Patient quality of life preservation - EORTC Quality of Life Questionnaire C30
Description
Quality of Life Questionnaire (QLQ) according to the European Organization for Research and Treatment of Cancer will be assessed by mean scores of the EORTC QLQ C-30 questionnaire (30 questions, score from 30 to 126) by local investigator or nurses and patient
Time Frame
Before surgery, pre-TemoRadiation visit, Cycle 1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11 and Month 18, or until progression up to 18 months
Title
Mean score Patient quality of life preservation - BN20 Quality of Life Questionnaire
Description
Quality of Life Questionnaire (QLQ) according to the European Organization for Research and Treatment of Cancer will be assessed will be assessed by means of the EORTC BN20 questionnaire (30 questions, score from 1 to 80) by local investigator or nurses and patient
Time Frame
Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Title
Karnofsky Performance Status (KPS)
Time Frame
Before surgery, Surgery (+/- device implantation), pre-TemoRadiation visit, start and day 15 of each cycle (=28 days) from Cycle 1 to 6, Month 11, Month 13, Month 15, or until progression up to 18 months, new surgery (debulking or device explantation)
Title
Mean score of Patient cognitive preservation
Description
Mini Mental Status Examination (30-point questionnaire, score from 1 to 30) mean score assessed by local investigator or nurses and patient
Time Frame
Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Title
Visual analogic scale (VAS) Pain score from surgical area
Description
pain score from surgical area using visual analogic scale (score 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible).
Time Frame
Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Title
Esthetical
Description
score in self-confidence concerning esthetical dimension of surgical scar using esthetical comfort question equivalent to q39 of QLQ-BR23 questionnaire: Does your skull scar induce any esthetic burden to you? Not at all A little Quite a bit Very much
Time Frame
Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Title
Safety : Type, frequency and severity of adverse events and serious adverse events
Description
Safety confirmation of efficient blood brain barrier opening procedure with the SonoCloud-9 system. Safety confirmation is assessed by the frequency and severity of Adverse Events (AE) (incidence of AE summarized by system organ class and/or preferred term and severity) based on the Common Terminology Criteria for Adverse Events, version 5.0.
Time Frame
From inclusion to end of treatment, up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria : Age ≥ 18 years , able and willing to give signed and informed consent. Inclusion for patients aged >70 years should be validated in neuro-oncology tumor board (RCP) MRI with suspicion of GBM or Patient with a newly histologically proven IDHwt GBM by previous stereotaxic biopsy or king size opened biopsy Karnofsky Performance Status ≥ 70 Patient eligible for a total or sub-total surgical tumor resection Maximal tumor enhancement diameter at inclusion (pre surgery) ≤ 70 mm in T1W MRI Patient eligible after surgery for the first line standard of care temoradiation and adjuvant TMZ (Stupp protocol, 54) Patient with adequate organ and bone marrow function within 14 days prior to registration, as defined below: Hemoglobin ≥ 10.0 g/dL Leukocytes ≥ 3,000/L Absolute neutrophil count ≥ 1,500/L Platelets ≥ 100,000/L Total bilirubin < 1.5 x ULN AST(SGOT)/ALT(SPGT) ≤ 3 x institutional ULN Alkaline phosphatase (ALP) < 3 x ULN Normal creatine clearance ≥ 60 mL/minute. Prothrombin time and partial thromboplastin time within institutional limits. For women of childbearing potential, a negative pregnancy test before inclusion and a medically acceptable method of birth control used throughout the study are required. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 1 month after the end of study visit A male patient must agree to use contraception as detailed in this Protocol during the treatment period and for at least 6 months after the last cycle of TMZ; he must refrain from donating sperm during this period Patient capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol Patient must be a beneficiary of or affiliated with a social security scheme Exclusion Criteria : Patients with multifocal tumor (unless all localized in a 70 mm diameter area accessible to ultrasound field) or located in posterior fossa tumor Patient with diffuse FLAIR abnormalities attributable to Gliomatosis Patients with evidence of uncontrolled intracranial pressure Patients with uncontrolled epilepsy Patients with medical need to continue antiplatelet or antithrombotic treatment Pregnant or breastfeeding women (blood pregnancy test) Patients with contra-indications to MRI or known sensitivity/allergy to gadolinium, or other intravascular contrast agents Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Luminity®/Definity® Patients with known intracranial aneurism, with and/or unremovable coils, clips, shunts, intravascular stents, wafer, non resorbable dura substitute, or reservoirs Patients with an uncontrolled intercurrent illness or any pre-existing comorbidities that in the Investigator's opinion may prevent the implantation of the device or may impair the ability of the patient to receive treatment with SonoCloud or may be cofounding for evaluation of the clinical trial. Patients with the following are not eligible: Known arterial hypertension grade 3 or higher without adequate control on medications Known or suspected unstable active or chronic infections requiring systemic treatment Known significant cardiac disease: right-to-left shunts, Unstable angina pectoris, Symptomatic congestive heart failure, Unstable cardiac arrhythmia Known significant pulmonary disease: severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, adult respiratory distress syndrome, or Pneumonitis Known Severe renal failure Known serious myelosuppression Known Psychiatric illness/social situations that would limit compliance with study requirements Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints Known immunodeficiency disease or treatments (HIV) Known viral or bacterial chronic/acute disease (potential blood borne infections that could result in meningitis or brain abscess) Patients under judicial protection Patients with any following prohibited treatments: Any investigational medicinal product within 30 days prior to inclusion and during the study Antibiotics with known neurotoxicity (eg, aminoglycosides, cephalosporin, quinolones), unless substitution is not possible, Non-absorbable material (dura matter substitute, hemostatic agent…) Any other drug according investigator to cause cerebral toxicity due to BBB opening Contra-indications to temozolomide Dacarbazine hypersensitivity Implantation of the SC-9 not possible according to neurosurgeon (any patient morphological characteristics (e.g. skin thin thickness >9mm), which, from neurosurgeons' opinion, prevent implantation of the device or may impair the ability of the patient to receive treatment with SonoCloud, would be excluded)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed IDBAIH, MD, PhD
Phone
33 1 42 16 03 85
Email
ahmed.idbaih@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre CARPENTIER, MD, PhD
Phone
33 1 42 16 34 05
Email
alexandre.carpentier@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed IDBAIH, MD, PhD
Organizational Affiliation
APHP-Sorbonne, Pitie Salpetriere Hospital, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katholieke Universiteit Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve DE VLEESCHOUWER, MD, PhD
Phone
32 16 3 44290
Facility Name
Centre hospitalier Universitaire d'Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe MENEI, MD, PhD
Phone
33 2 41 35 48 22
Facility Name
Groupe Hospitalier Saint-André
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte BRONNIMANN, MD
Phone
33 5 57 82 17 37
Facility Name
Hospices Civils de Lyon, Hôpital Pierre Wertheimer
City
Bron
ZIP/Postal Code
60900
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François DUCRAY, MD, PhD
Phone
33 4 72 35 78 06
Facility Name
AP-HM, La Timone, Hôpital Universitaire
City
Marseille
ZIP/Postal Code
13000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier CHINOT, MD, PhD
Phone
33 4 91 38 65 69
Facility Name
APHP-Sorbonne, Pitié Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed IDBAIH, MD, PhD
Phone
33 1 42 16 03 85
Email
ahmed.idbaih@aphp.fr
First Name & Middle Initial & Last Name & Degree
Alexandre CARPENTIER, MD, PhD
Phone
33 1 42 16 34 05
Email
alexandre.carpentier@aphp.fr
Facility Name
Centre hospitalier universitaire vaudois CHUV
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas HOTTINGER, MD, PhD
Phone
41 21 314 6541

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

Learn more about this trial

Innovative SonoCloud-9 Device for Blood Brain Barrier Opening in First Line Temozolomide Glioblastoma Patients.

We'll reach out to this number within 24 hrs