UnknownPhase 2

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

Belgium, France66 participantsStarted 2021-09-11

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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

What they're measuring

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.

Timeframe: Between randomisation and 18 months after the last inclusion.

Trial details

NCT IDNCT04614493

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03

Contact for this trial

Ahmed IDBAIH, MD, PhD

33 1 42 16 03 85 ahmed.idbaih@aphp.fr

View on ClinicalTrials.gov More Initial Radiological Diagnosis Eligible for Tumor Resection trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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

What they're measuring

Timeframe: Between randomisation and 18 months after the last inclusion.

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria