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NCT04082520 · ClinicalTrials.gov registry record · Phase 2
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
A Phase 2 study of Recurrent Meningioma and Grade 2 Meningioma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT04082520: Recruiting Phase 2 study of Recurrent Meningioma and Grade 2 Meningioma, sponsored by Mayo Clinic.
NCT04082520 is a Phase 2 study of Recurrent Meningioma and Grade 2 Meningioma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 41 participants, below the 47-participant average among 6 other Recurrent Meningioma trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04082520, a Phase 2 study of Recurrent Meningioma and Grade 2 Meningioma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill tumor cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment. WHO Grade I and Cohort WHO II/III cohorts will be evaluated.
Primary Outcome
Defined as the number of evaluable patients not having progressive disease or death within six months of the first day of treatment.
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Positron Emission Tomography
- OTHER Questionnaire Administration
- RADIATION Gallium Ga 68-DOTATATE
- DRUG Lutetium Lu 177 Dotatate
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2020-04-14 |
| Est. Completion | 2031-01-06 |
| Phase | Phase 2 |
What NCT04082520 shows while recruiting
NCT04082520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 47-participant average among 6 other Recurrent Meningioma trials with a reported enrollment target (13% lower).
The record links to 5 conditions, with Recurrent Meningioma appearing as the primary indexed condition, and to 5 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT04082520 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04082520 about?
NCT04082520 is a clinical study titled "Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy". This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is...
What is the current status of trial NCT04082520?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2020-04-14. Estimated completion is 2031-01-06.
What conditions does trial NCT04082520 study?
This clinical trial studies the following conditions: Recurrent Meningioma, Grade 2 Meningioma, Grade 3 Meningioma, Grade 1 Meningioma, Unresectable Meningioma.
What interventions are being tested in trial NCT04082520?
The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE), Questionnaire Administration (OTHER), Gallium Ga 68-DOTATATE (RADIATION), Lutetium Lu 177 Dotatate (DRUG).
Who is sponsoring clinical trial NCT04082520?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04082520 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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