NCT03971461

Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma

A Single Arm, Open-label, Multicenter Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meningioma

Interventions

Type	Name	Description
DRUG	Lutathera	administered intravenously every 8 weeks for a total of 4 doses

Timeline

• Start date: 2019-05-15
• Primary completion: 2025-04-18
• Completion: 2027-01-01
• First posted: 2019-06-03
• Last updated: 2026-03-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study