Multicenter Evaluation in Patients With MEningiomas of the Response to Treatment With 177LUTEtium-oxodotreotide (MELUTE)

Multicenter Evaluation in Patients With MEningiomas Expressing Somatostatin Type 2 Receptors and After Failure of Standard Treatments, of the Response to Treatment With 177LUTEtium-oxodotreotide

Meningiomas are the most common primary tumors of the central nervous system, representing more than a third of tumors.Current conventional treatments for meningioma are surgery and radiotherapy. When these treatments are no longer feasible, meningiomas are considered refractory regardless of their grade. Some meningiomas express somatostatin type 2 receptors and can be treated with lutathera. This study aims to evaluate the response to treatment in this pathology

Study Overview

• Status: Completed
• Conditions: Meningioma

Detailed Description

In nuclear medicine, peptide receptor radionuclide therapy with 177Lu-oxodotreotide, deploys an octreotide-like effect and appears very promising, with a preliminary progression free survival at 6 months of 94% and overall survival at 12 months of 88% in grade 1 meningiomas, and 28% with an overall survival at 12 months of 65% in grades 2 and 3 meningiomas. These results are nevertheless the result of a meta-analysis obtained from series of patients limited in number and heterogeneous in terms of type of treatment modality.

At the request of healthcare professionals and in consultation with the Advanced Accelerator Applications laboratory, the Agency of the drug security has developed a compassionate prescribing framework aimed at securing the use of Lutathera in meningiomas of all grades, expressing type 2 somatostatin in imaging of nuclear medicine, after failure of the standard treatment (surgery, radiotherapy/radio-surgery) or impossibility of carrying it out (multiple lesions, inaccessible lesions), at the suggestion of the national comitee OMEGA (April 6, 2022). This cohort has the advantage of being consistent and homogeneous in terms of type of treatment and method of administration.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Vandoeuvre/Les/Nancy, France, 54511
    • CHRU of Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients suffering from refractory meningioma of any grade who have benefited from treatment with Lutathera within the framework of compassionate prescription and who have received the information letter on the objectives of the research and who have not not opposed to the use of their data, and for which the magnetic resonance imaging will be available to be sent to a server for centralized rereading.

Description

Inclusion Criteria:

• Patients who have benefited from treatment with Lutathera® within the framework of compassionate prescription in a refractory meningioma of any grade
• Patient informed via an information and non-opposition to the use of their pseudonymized data for research purposes (research objectives clearly explained in the letters)

Exclusion Criteria:

-Patient opposition to the use of their data for this research

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the response to treatment with Lutathera® in patients with meningioma expressing somatostatin type 2 receptors, and after failure of standard treatments, for whom compassionate access to this treatment has been requested.	Progression-free survival at 6 months (according to RANO criteria)	6 months
To evaluate the response to treatment with Lutathera® in patients with meningioma expressing somatostatin type 2 receptors, and after failure of standard treatments, for whom compassionate access to this treatment has been requested.	Overall survival at 12 months (according to RANO criteria)	12 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: ANTOINE VERGER, MD, PhD, CHRU Nancy

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Meningioma
• Other Study ID Numbers: 2023PI224

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No