Clinical trial NCT06255249: Multicenter Evaluation in Patients With MEningiomas of the Response to Treatment With 177LUTEtium-oxodotreotide
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningioma
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre/Les/Nancy
country: France
facility: CHRU of NANCY
Study officials:
affiliation: CHRU Nancy
name: ANTOINE VERGER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: