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NCT03744026 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9
A Phase 1 study, sponsored by CarThera.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT03744026: Completed Phase 1 study, sponsored by CarThera.
NCT03744026 is a Phase 1 study that has completed, run by CarThera. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03744026, a Phase 1 study, has completed, sponsored by CarThera.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Carboplatin
- DEVICE SonoCloud-9
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-02-18 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 1 |
What the finished NCT03744026 record still lists
NCT03744026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Carboplatin is the first listed.
NCT03744026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03744026 about?
NCT03744026 is a clinical study titled "Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9". 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...
What is the current status of trial NCT03744026?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2019-02-18. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT03744026?
The interventions under investigation include: Carboplatin (DRUG), SonoCloud-9 (DEVICE).
Who is sponsoring clinical trial NCT03744026?
This trial is sponsored by CarThera, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03744026's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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