SONOKID. A Phase I Trial Evaluating the Tolerability of Repeated Blood-Brain Barrier Disruption by Ultrasound Prior to Chemotherapy in the Treatment of Recurrent Supratentorial Primary Malignant Brain Tumors in Children.

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516169-35-00

Acronym

D20181321

Enrollment

Registered

2024-11-19

Start date

2023-02-06

Completion date

Unknown

Last updated

2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrent primary supratentorial malignant brain tumors in children

Brief summary

Absence of Dose Limiting Toxicity (DLT) directly related to the ultrasound emission from the SonoCloud-9® device (3 emitters), assessed at each cycle

Detailed description

Evaluation of the grade of blood-brain barrier (BBB) opening by ultrasound as described by Carpentier et al., overall survival (OS) at 3 months and progression-free survival (PFS) at 6 months, Evaluation of the occurrence of allergic and/or cardiac complications., Evaluation of complications related to implantation or sonications (excluding ultrasound effects), evaluation of implantation and connection procedures, and assessment of the device's bioavailability and resistance., Evaluation of clinical and/or radiological complications beyond the first treatment cycle., Assessment of circulating tumor DNA, antigens or circulating tumor markers, and circulating tumor cells

Interventions

DRUGCARBOPLATIN

DRUGSonoVue 8 microlitres/mL powder and solvent for dispersion for injection

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Absence of Dose Limiting Toxicity (DLT) directly related to the ultrasound emission from the SonoCloud-9® device (3 emitters), assessed at each cycle	—

Secondary

Measure	Time frame
Evaluation of the grade of blood-brain barrier (BBB) opening by ultrasound as described by Carpentier et al., overall survival (OS) at 3 months and progression-free survival (PFS) at 6 months, Evaluation of the occurrence of allergic and/or cardiac complications., Evaluation of complications related to implantation or sonications (excluding ultrasound effects), evaluation of implantation and connection procedures, and assessment of the device's bioavailability and resistance., Evaluation of clinical and/or radiological complications beyond the first treatment cycle., Assessment of circulating tumor DNA, antigens or circulating tumor markers, and circulating tumor cells	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026