Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9 (SC9-GBM-01)
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|ClinicalTrials.gov Identifier: NCT03744026|
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : July 9, 2019
Recurrent glioblastoma (GBM) is a disease with high unmet clinical need. The standard of care for patients with GBM includes surgery, radiotherapy and chemotherapy. Despite this aggressive treatment, the overall median survival of patients with GBM remains at 15-20 months.
In more than 95% of cases, tumor recurrence is observed within 2 cm to 3 cm of the resection cavity within 4-7 months after initial treatments. One of the main causes of recurrence is the inability of chemotherapies to enter the brain from the systemic circulation due to the blood-brain barrier (BBB). The BBB is unique to cerebral blood vessels and blocks most drugs from entering the brain in sufficient concentrations.
The SonoCloud-9 (SC9) System delivers ultrasound to locally and transiently increase the permeability of the BBB to allow the passage of drugs into the cerebral parenchyma. The SC9 is dimensioned to cover the resection area and surrounding tissues in patients with recurrent GBM. The large sonicated volume covered by the SC9 device allows for broad BBB disruption and should allow for carboplatin chemotherapy to penetrate the surrounding tumor infiltrative area. By enhancing drug concentrations, it is hypothesized that further disease progression will be prevented.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma, Adult||Device: SonoCloud-9 Drug: Carboplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Safety and the Efficacy of Transient Opening of the Blood-brain Barrier (BBB) by Low Intensity Pulsed Ultrasound With the SonoCloud-9 Implantable Device in Recurrent Glioblastoma Patients Eligible for Surgery and for Carboplatin Chemotherapy|
|Actual Study Start Date :||February 18, 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
Experimental: SonoCloud-9 Ultrasound + Carboplatin
SonoCloud-9 Carboplatin: 6 cycles (every 4 weeks)
Escalating numbers of ultrasound beams at constant acoustic pressure
Dose of carboplatin infusion is AUC4-6
- Dose limiting toxicity (DLT) of number of activated ultrasound beams [ Time Frame: 15 days after the first sonication treatment ]DLT will be evaluated using imaging (MRI) and clinical examination, as CTCAE that occurs within 2 weeks of the first sonication and that does not respond to optimal medical management (including steroids) within 7 days.
- Blood-Brain Barrier (BBB) opening [ Time Frame: At the end of the first three sonication treatments (treatment occurs every 4 weeks) ]BBB opening will be evaluated by contrast-enhanced T1w magnetic resonance imaging (MRI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744026
|Contact: Carole DESSEAUX||+33 (0)1 57 27 46 email@example.com|
|Hôpital Neurologique Pierre Wertheimer||Recruiting|
|Bron, France, 69500|
|Contact: François DUCRAY, MD|
|Contact: Ahmed IDBAIH, MD|
|Sub-Investigator: Alexandre CARPENTIER, MD|