drugset / Trial / NCT04997317

Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide

NCT04997317 ↗

RandomizedCrossoverOpen-labelTreatment

Summary

Meningiomas are known to be the most frequent intracranial neoplasms and account for approx. 25-33% of all intracranial tumours.Targeted radionuclide therapy with radiolabelled somatostatin analogues, also called Peptide Receptor Radionuclide Therapy (PRRT), has proven to be an effective treatment in metastatic intestinal neuroendocrine tumours and is currently used in advanced, recurrent or progressive meningiomas with promising results. In this study, the therapeutic index of a standard and newly developed radiolabelled somatostatin antagonist will be evaluated and compared in PRRT. In a second step, safety and efficacy of the latter will be assessed.

Timeline

Start
2021-04-21
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator 177Lu-DOTA-JR11 Unknown 300 ug Intravenous
Comparator 177Lu-DOTA-JR11 Unknown 1300 ug Intravenous
Comparator 177Lu-DOTA-JR11 Unknown 4500 mbq Intravenous
Comparator 177Lu-DOTA-JR11 Unknown 7400 mbq Intravenous
Comparator Lutetium Lu 177-Edotreotide Peptide 200 ug Intravenous
Comparator Lutetium Lu 177-Edotreotide Peptide 4500 mbq Intravenous
Comparator Lutetium Lu 177-Edotreotide Peptide 7400 mbq Intravenous

Indications