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Trial intelligence / Profile preview
Lutathera in Patients With Inoperable, Progressive Meningioma
NCT04082520Phase 2
Key facts
- Status
- Recruiting
- Start
- Apr 2020
- Primary completion
- Sep 2027
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Peptides, Small Molecules
- Conditions
- meningioma
01
Overview
Phase 2, open-label, single-arm trial of lutetium Lu 177 dotatate in meningioma, sponsored by Mayo Clinic. Primary endpoint: Progression-Free Survival at 6 months. Started Apr 2020; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (gallium Ga 68-DOTATATE PET/MRI, Lutathera)
Patients receive gallium Ga 68-DOTATATE IV and undergo a PET/MRI or PET/CT before cycles 1 and 4. Patients then receive lutetium Lu 177 dotatate IV over 30-40 minutes. Treatment repeats every 8 weeks for up to 4 cycles.
03
Who it enrols
Patients with recurrent, progressive meningioma (Grade 1-3) previously treated with radiation therapy, with measurable disease, adequate organ function, and positive 68Ga-DOTATATE PET imaging.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Progression-Free Survival
Adverse Events
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