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

NCT06255249 | Completed

• 1 other identifier: 2023PI224
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meningioma

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU of NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• ANTOINE VERGER, MD, PhD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator coordinator

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: October 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

FR (1)