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NCT04305470 · ClinicalTrials.gov registry record · Phase 3
Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma
A Phase 3 study, sponsored by NX Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
NCT04305470: Completed Phase 3 study, sponsored by NX Development.
NCT04305470 is a Phase 3 study that has completed, run by NX Development. The registered enrollment target is 108 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04305470, a Phase 3 study, has completed, sponsored by NX Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
Study Summary
This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real time detection and visualization of meningiomas during tumor resection surgery. The study is planned to run for 15 months with individual study participation lasting for approximately 2 months.
Primary Outcome
Responders are defined as the percentage of participants among all participants receiving Gleolan (the Intent to Image Population) who had at least one indeterminate tissue or unexpected fluorescent end of surgery (EOS) tissue where Gleolan-induced PpIX fluorescence status was consistent with central laboratory histology. For a participant to be considered a success, only biopsies considered 'non-obvious' for tumor status by an external panel of neurosurgeons who reviewed videos and images were
Interventions
- DRUG Gleolan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2020-10-28 |
| Est. Completion | 2022-12-13 |
| Phase | Phase 3 |
What the finished NCT04305470 record still lists
NCT04305470 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Gleolan is the first listed.
NCT04305470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04305470 about?
NCT04305470 is a clinical study titled "Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma". This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real time detection and visualization of meningiomas during tumor resection surgery. The study is planned to run for 15 months with individual study part...
What is the current status of trial NCT04305470?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2020-10-28. Estimated completion is 2022-12-13.
What interventions are being tested in trial NCT04305470?
The interventions under investigation include: Gleolan (DRUG).
Who is sponsoring clinical trial NCT04305470?
This trial is sponsored by NX Development, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04305470's enrollment target sits among peer trials
108 1664th of 2000 higher than 335 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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