The aim of this study is to determine the recommended dose of [177Lu]Lu-DOTA-TATE in combination with standard treatment or as a single agent in three different groups of participants with glioblastoma. In addition, this study examines the safety of [68Ga]Ga-DOTA-TATE and describes its uptake characteristics in participants with glioblastoma.
Aim of the study
Before an investigational substance or drug is used to treat a disease, it must be scientifically tested on study participants. Therefore, we would like to assess the safety and determine the appropriate dose of [177Lu]Lu-DOTA-TATE (also known as "Lutathera®") in combination with the current standard treatment with radiotherapy with or without temozolomide in patients with newly diagnosed glioblastoma.
Who can take part?
Patients with newly diagnosed glioblastoma with or without methylated MGMT, participants with relapsed glioblastoma
Procedure
If you decide to participate in the study, you will receive Lutathera as a treatment for recurrent glioblastoma. In addition, an imaging agent [68Ga]Ga-DOTA-TATE (also called "NetSpot®") is administered to search for a specific target, the somatostatin receptor in your tumor, before the start of treatment.
Compensation
None
Original study name
A Phase Ib dose-finding study to evaluate the safety and efficacy of [177Lu]Lu-DOTA-TATE in newly diagnosed glioblastoma in combination with radiotherapy with or without temozolomide and in recurrent glioblastoma as a single agent
BASEC number
2022-00431
Financial support from
Novartis