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Trial Title:
Multicenter Evaluation in Patients With MEningiomas of the Response to Treatment With 177LUTEtium-oxodotreotide
NCT ID:
NCT06255249
Condition:
Meningioma
Conditions: Official terms:
Meningioma
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Start date:
October 30, 2024
Completion date:
March 30, 2025
Lead sponsor:
Agency:
Central Hospital, Nancy, France
Agency class:
Other
Source:
Central Hospital, Nancy, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06255249
