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

NCT04614493 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-03-29

No results posted yet for this study

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.

Conditions

  • 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

Interventions

DEVICE

SonoCloud-9 (SC9) device

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

DRUG

Temozolomide according Stupp protocol

daily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Ahmed IDBAIH, MD, PhD · APHP-Sorbonne, Pitie Salpetriere Hospital, Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-11
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Belgium
  • France
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614493 on ClinicalTrials.gov