Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 5:21 AM
Study NCT ID:
NCT06614205
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2024-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma
Status:
COMPLETED
Status Verified Date:
2025-02
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:
DATUM
Brief Summary:
The hypothesis for this study is that there is a dose-response relationship in patients treated with 177Lu-DOTATATE for meningiomas.
Detailed Description:
Dosimetry is essential for Peptide Receptor Radionuclide Therapy (PRRT) of meningiomas, to predict efficacy and dose-effect relationships at the individual level, and to move towards personalized medicine. Due to the increasing therapeutic applications of Lutathera, the European Association of Nuclear Medicine (EANM) recently issued recommendations on the dosimetry of 177Lu-labeled somatostatin analogues. Nevertheless, despite these recommendations, the evaluation of meningioma tumor dosimetry in Peptide Receptor Radionuclide Therapy studies is not systematic, which has not enabled us to clearly determine the dose delivered to the meningioma lesion in these treatments and the possible dose-response relationship in this type of treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: