drugset / Trial / NCT03971461

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

NCT03971461

Phase 2 Active not recruiting 32 enrolled NYU Langone Health
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-05-15
Primary completion
2025-04-18
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-DOTATATE Peptide Intravenous

Indications