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NCT03086616 · ClinicalTrials.gov registry record · Phase 1
CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With Diffuse Intrinsic Pontine Glioma (DIPG) (PNOC 009)
A Phase 1 study, sponsored by Sabine Mueller, MD, PhD.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03086616: Completed Phase 1 study, sponsored by Sabine Mueller, MD, PhD.
NCT03086616 is a Phase 1 study that has completed, run by Sabine Mueller, MD, PhD. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03086616, a Phase 1 study, has completed, sponsored by Sabine Mueller, MD, PhD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase I and Early Efficacy Study of Convection Enhanced Delivery (CED) of irinotecan liposome injection (nal-IRI) Using Real Time Imaging with Gadolinium in Children with Diffuse Intrinsic Pontine Glioma who have completed focal radiotherapy
Primary Outcome
Safety of repeated CED of nal-IRI following standard of care focal radiotherapy will be assessed by monitoring for adverse events, scheduled laboratory assessments, vital sign measurements, and physical examinations for subjects who receive the vaccination. The severity of toxicities will be graded according to the NCI CTCAE v4.0. Adverse events and clinically significant laboratory abnormalities (meeting Grade 3, 4, or 5 criteria according to CTCAE) will be summarized by maximum intensity and r
Interventions
- DRUG Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-10-31 |
| Est. Completion | 2021-10-04 |
| Phase | Phase 1 |
What the finished NCT03086616 record still lists
NCT03086616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI) is the first listed.
NCT03086616 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03086616 about?
NCT03086616 is a clinical study titled "CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With Diffuse Intrinsic Pontine Glioma (DIPG) (PNOC 009)". This is a Phase I and Early Efficacy Study of Convection Enhanced Delivery (CED) of irinotecan liposome injection (nal-IRI) Using Real Time Imaging with Gadolinium in Children with Diffuse Intrinsic Pontine Glioma who have completed focal radiotherapy
What is the current status of trial NCT03086616?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-10-31. Estimated completion is 2021-10-04.
What interventions are being tested in trial NCT03086616?
The interventions under investigation include: Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI) (DRUG).
Who is sponsoring clinical trial NCT03086616?
This trial is sponsored by Sabine Mueller, MD, PhD, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03086616's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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