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Safety of BBB Opening With the SonoCloud (SONOCLOUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02253212
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 29, 2014
First Posted Date  ICMJE October 1, 2014
Last Update Posted Date October 12, 2018
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
Safety of transient disruption of the blood-brain barrier using the SonoCloud system in patients with recurrent glioblastoma. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
• To determine the safety of transient disruption of the blood-brain barrier using the SonoCloud system in patients with recurrent glioblastoma. [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
  • Maximum tolerated dose of ultrasound with the SonoCloud system for transient disruption of the BBB. [ Time Frame: 12 months ]
  • Quantification of the disruption of the BBB by the SonoCloud system using dynamic T1 contrast-enhanced MRI. [ Time Frame: 12 months ]
  • Progression-free survival in patients treated with the SonoCloud system in combination with carboplatin chemotherapy. [ Time Frame: 12 months ]
  • Overall survival in patients treated with the SonoCloud system in combination with carboplatin chemotherapy. [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • • To determine the maximum tolerated dose of ultrasound with the SonoCloud system for transient disruption of the BBB. [ Time Frame: 6 months ]
  • • To quantify the disruption of the BBB by the SonoCloud system using dynamic T1 contrast-enhanced MRI. [ Time Frame: 6 months ]
  • • To determine progression-free survival in patients treated with the SonoCloud system in combination with carboplatin chemotherapy. [ Time Frame: 12 months ]
  • • To determine overall survival in patients treated with the SonoCloud system in combination with carboplatin chemotherapy. [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of BBB Opening With the SonoCloud
Official Title  ICMJE A Study to Evaluate the Safety of Transient Opening of the Blood-Brain Barrier by Low Intensity Pulsed Ultrasound With the SonoCloud Implantable Device in Patients With Recurrent Glioblastoma Before Chemotherapy Administration
Brief Summary

PURPOSE: The purpose of this study is to determine whether transient opening of the blood-brain barrier by pulsed ultrasound using the SonoCloud implantable ultrasound device is safely tolerated in patients with recurrent glioblastoma immediately before systemic delivery of carboplatin-based chemotherapy.

STUDY HYPOTHESIS: The blood-brain barrier can be safely opened using pulsed ultrasound prior to chemotherapy administration in patients with recurrent glioblastoma. Transient opening of the blood-brain barrier by pulsed ultrasound will increase the glioblastoma exposure to carboplatin-based chemotherapy and increase progression-free and overall survival in patients with recurrent glioblastoma.

Detailed Description

For patients with recurrent malignant gliomas, who have already been treated by a combination of surgery, radiation therapy and/or chemotherapy, few treatment options currently exist. Salvage therapies typically consist of systemic administration of chemotherapy agents, which have been shown to have limited effectiveness as median survival in this patient group is currently only 6 months.

One limitation to the efficacy of systemic chemotherapy in the treatment of brain tumors is the blood-brain barrier (BBB). To enhance the delivery of systemically administered chemotherapy agents to brain tumors, an implantable ultrasound device was developed that can be used to temporarily disrupt the BBB. Delivery of pulsed ultrasound, in combination with an ultrasound contrast agent, has been shown to temporarily disrupt the BBB for a duration of more than 6 hours and allow for a significantly increased penetration of systemically administered chemotherapy drugs in pre-clinical studies.

This study will evaluate the safety of temporary disruption of the BBB during carboplatin chemotherapy delivery in patients with recurrent glioblastoma. This study will also evaluate the maximum tolerated dose of ultrasound that can be used to disrupt the BBB.

The use of dynamic contrast-enhanced MRI will be evaluated for determining the extent and magnitude of BBB opening. Clinical efficacy (Survival) and radiological efficacy (Progression Free Survival) will also be evaluated as secondary endpoints.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioblastoma
  • Glioma
  • Brain Tumor
Intervention  ICMJE
  • Device: SonoCloud
    SonoCloud : dose escalation
  • Drug: Carboplatin
    Carboplatin : min 6 cycles - individual dose determination according to renal function and AUC
Study Arms  ICMJE Experimental: SonoCloud + carboplatin
SonoCloud : dose escalation Carboplatin : min 6 cycles - individual dose determination according to renal function and AUC
Interventions:
  • Device: SonoCloud
  • Drug: Carboplatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
27
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2014)
11
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Age greater than 18 years.
  • Subjects with recurrent glioma who have failed standard therapy with surgery and/or treatment with radiation and temozolomide.
  • Patient eligible for Carboplatin-based chemotherapy
  • Contrast-enhanced tumor less than 35 mm in diameter
  • No risk of cerebral herniation
  • Able to tolerate pre/post procedure steroid treatment
  • Social security affiliated (in France)
  • Able and willing to give signed and informed consent
  • Normal biological status
  • Hemoglobin ≥ 10 g/dl
  • Platelets ≥ 100000/mm3
  • Neutrophils ≥ 1500/mm3
  • Normal creatine clearance ≥ 60ml/mn
  • ASAT < 3 N
  • ALAT < 3 N
  • Normal Bilirubin Level < 1.5 N
  • Alkaline Phosphatase < 3 N
  • INR < 1.5
  • Prothrombin Level ≥ 70%

Exclusion criteria:

  • Allergic to Iodine, Gadolinium, Xylocain
  • Contra-indications to echographic contrast agent (microbubbles)
  • Severe Renal insufficiency
  • Hepatic insufficiency
  • Possible toxic treatment for CNS
  • Previously infected surgical field
  • Uncontrolled epilepsy
  • MRI contra-indications
  • Hemostasis troubles thrombopenia <75.000, TP <60%, INR >1.5, anti-platelet or anticoagulant therapy on-going)
  • Active phlebitis or active pulmonary embolism
  • Pregnant or currently breast-feeding
  • Patients under judicial protection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02253212
Other Study ID Numbers  ICMJE P120905
2014-000393-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmed Idbaih, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP