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NCT05278208 · ClinicalTrials.gov registry record · Phase 1
Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
A Phase 1 study of High Grade Glioma and Medulloblastoma, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 4
- Study locations
NCT05278208 is a Phase 1 study of High Grade Glioma and Medulloblastoma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 65 participants, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target. The trial reports 4 study locations across 3 states.
The verdict
NCT05278208, a Phase 1 study of High Grade Glioma and Medulloblastoma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)
Conditions Studied
Interventions
- DRUG LUTATHERA® (Lutetium Lu 177 dotatate)
Study Locations (4)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Colorado
- Children's Hospital Colorado - Aurora
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05278208
The ClinicalTrials.gov registry entry for NCT05278208 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 1 intervention - of which LUTATHERA® (Lutetium Lu 177 dotatate) is the first listed.
NCT05278208 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Ohio, Colorado, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05278208 about?
NCT05278208 is a clinical study titled "Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors". This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up t...
What is the current status of trial NCT05278208?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2022-11-21. Estimated completion is 2027-11.
What conditions does trial NCT05278208 study?
This clinical trial studies the following conditions: High Grade Glioma, Medulloblastoma, Meningioma, Recurrent Malignant Glioma, Recurrent Medulloblastoma.
What interventions are being tested in trial NCT05278208?
The interventions under investigation include: LUTATHERA® (Lutetium Lu 177 dotatate) (DRUG).
Who is sponsoring clinical trial NCT05278208?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05278208 being conducted?
This trial has 4 study locations across Colorado, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.