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NCT03971461 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma
A Phase 2 study of Meningioma, sponsored by NYU Langone Health.
- Active
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT03971461: Active Phase 2 study of Meningioma, sponsored by NYU Langone Health.
NCT03971461 is a Phase 2 study of Meningioma that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 32 participants, below the 98-participant average among 21 other Meningioma trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03971461, a Phase 2 study of Meningioma, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
This single arm, open-label study will evaluate the efficacy of Lutathera (177Lu-DOTATATE) administered intravenously every 8 weeks for a total of 4 doses in patients with progressive WHO I-III or residual high-risk Ga-DOTATATE PET-MRI positive meningioma. Ga-DOTATATE PET-MRI scans will be obtained prior to initiation of Lutathera treatment and 6 months after the initiation of Lutathera treatment. The latter will be performed within the 14 days prior to the last dose of Lutathera treatment.
Primary Outcome
proportion of subjects who achieve a complete response (CR), partial response (PR), or stable disease (SD) at 6 months from start of Lutathera treatment. Radiographic treatment response will be assessed by measuring the bidirectional tumor diameters on contrast-enhanced MRI in patients who received at least one dose of Lutathera compared to baseline measurements at time of study enrollment
Conditions Studied
Interventions
- DRUG Lutathera
Study Locations (2)
New York
- NYU Langone Health - New York
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-05-15 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What the registry record for NCT03971461 still lists
NCT03971461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 98-participant average among 21 other Meningioma trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Meningioma appearing as the primary indexed condition, and to 1 intervention - of which Lutathera is the first listed.
NCT03971461 reports a single indexed study location in New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT03971461 about?
NCT03971461 is a clinical study titled "Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma". This single arm, open-label study will evaluate the efficacy of Lutathera (177Lu-DOTATATE) administered intravenously every 8 weeks for a total of 4 doses in patients with progressive WHO I-III or residual high-risk Ga-DOTATATE PET-MRI positive meningioma. Ga-DOTATATE PET-MRI scans will be obtained ...
What is the current status of trial NCT03971461?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2019-05-15. Estimated completion is 2027-01.
What conditions does trial NCT03971461 study?
This clinical trial studies the following conditions: Meningioma.
What interventions are being tested in trial NCT03971461?
The interventions under investigation include: Lutathera (DRUG).
Who is sponsoring clinical trial NCT03971461?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03971461 being conducted?
This trial has 2 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Meningioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03971461's enrollment target sits among peer trials
32 14th of 21 higher than 8 of 21 other Meningioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Meningioma 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.
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