Clinical trial · Interventional
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption (BBBD) With Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy
NCT04440358CI-TRIAL-00101103completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Exablate BBBD | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exablate BBBD with carboplatin
- description
- Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to carboplatin administration.
- interventionNames
- Device: Exablate BBBD
- Drug: Carboplatin
Primary outcomes (2)
- measure
- Occurrence of Adverse Events
- timeFrame
- Through study completion, an average of 12 months
- description
- All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria
- measure
- Contrast intensity on MR imaging
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Must be between 18-80 years old * Histologically confirmed glioblastoma * Planned for Carboplatin monotherapy * Be willing and able to provided written informed consent/assent * Tumor progression after first line therapy * Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy * Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception * Able to communicate verbally Exclusion Criteria: * Acute intracranial hemorrhage * Ferrous metallic implanted objects in the skull or brain * Prior toxicity with carboplatin chemotherapy * Women who are pregnant or breastfeeding * Cerebellar spinal cord or brain stem tumor * Known active Hepatitis B or Hepatitis C or HIV * Significant depression not adequately controlled * Cardiac disease or unstable hemodynamics * Severe hypertension * History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage * Active drug or alcohol use disorder * Known sensitivity to gadolinium-based contrast agents * Known sensitivity or contraindications to ultrasound contrast agent or perflutren * Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices * Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication * Severely impaired renal function * Right to left or bi-directional cardiac shunt * Cranial or systemic infection requiring antibiotics * Known additional malignancy that is progression or require active treatment
References
Publications (0)
Data not yet available
No reference posted for this study.