Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326190
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-14
Brief Title:
177Lu-DOTATATE for Recurrent Meningioma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
177Lu-DOTATATE for Recurrent Meningioma a Randomized Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUMEN-1
Brief Summary:
Novel treatments are urgently needed for meningiomas progressing after local therapies surgery radiotherapy So far no effective systemic therapies are known in this situation The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine theranostic concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand
The rationale for the LUMEN-1 trial is based on the following a high somatostatin receptor SSTR expression in meningiomas b wide-spread availability of clinically established SSTR-PET imaging c proven efficacy of SSTR-targeting radioligand therapy using 177LuLu-DOTATATE in another tumor type neuroendocrine tumors and d promising experiences with 177LuLu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas LUMEN-1 is the first randomized clinical trial to investigate 177LuLu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area
The rationale for the LUMEN-1 trial is based on the following a high somatostatin receptor SSTR expression in meningiomas b wide-spread availability of clinically established SSTR-PET imaging c proven efficacy of SSTR-targeting radioligand therapy using 177LuLu-DOTATATE in another tumor type neuroendocrine tumors and d promising experiences with 177LuLu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas LUMEN-1 is the first randomized clinical trial to investigate 177LuLu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None