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Completed

NCT Number: NCT06255249

Multicenter Evaluation in Patients With MEningiomas 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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU of NANCY

Vandœuvre-lès-Nancy, 54511, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 6 months

    Progression-free survival at 6 months (according to RANO criteria)

  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.

    Time frame: 12 months

    Overall survival at 12 months (according to RANO criteria)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: MELUTE

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 13, 2024
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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