Clinical TrialID 8200
FUS Etoposide for DMG
NCT05762419
Diffuse Intrinsic Pontine Glioma|Diffuse Midline Glioma, H3 K27M-Mutant
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8200
- Evidence Id
- 8200
- Core Evidence Id
- 8200
- Source Clinical Trial Id
- 8198
- Herb2 Clinical Trial Id
- HBCT008198
- Nct Id
- NCT05762419
- Title
- FUS Etoposide for DMG
- Status
- Active_Not_Recruiting
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Diffuse Intrinsic Pontine Glioma|Diffuse Midline Glioma, H3 K27M-Mutant
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Etoposide; Oral, 50 Mg|DEVICE: Focused ultrasound with neuro-navigator-controlled sonication
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult
- Enrollment
- 10
- Outcome Measure
- Number of total adverse events, This is to evaluate the safety of using focused ultrasound to open the blood brain barrier at one or two sites for administration of etoposide in children with progressive diffuse midline glioma. Safety will be assessed by adverse events as per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (including abnormalities from physical and neurologic examinations, laboratory values, and radiographic results)., Up to 90 days after the end of the last focused ultrasound treatment|Number of patients with successful opening of the blood brain barrier, This is to evaluate the feasibility of using FUS to open the blood brain barrier at one or two sites for administration of etoposide in children with progressive diffuse midline glioma. The study defines feasibility as successful opening of the blood brain barrier., Treatment will consist of up to 4 cycles, each lasting 28 days. During the first 2 weeks of each cycle, subjects will receive FUS therapy for a maximum of 3 times per week, concurrent with etoposide.
- Sponsor Collaborator
- Cheng-Chia (Fred) Wu|Focused Ultrasound Foundation
- Funded By
- OTHER
- Location
- Columbia University Irving Medical Center, New York, New York, 10032, United States
- Other Id
- AAAU1228
- Start Date
- 2023-06-05
- Primary Completion Date
- 2025-01
- Completion Date
- 2027-01
- First Posted
- 2023-03-09
- Results First Posted
- Last Update Posted
- 2024-05-17
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05762419
- Title Cn
- Title En
- FUS Etoposide for DMG
- Bilingual Status
- semi_complete