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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 is a Phase 1 study that has completed, run by CarThera. The registered enrollment target is 38 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03744026
The ClinicalTrials.gov registry entry for NCT03744026 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CarThera, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Carboplatin is the first listed.
NCT03744026 reports 0 study locations.
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.
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