Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
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.