Search for Circulating Tumour Cells in the Blood and/or Cerebrospinal Fluid in Patients With Recurrent Aggressive Meningiomas: Proof-of-concept Study (BIOLIMEN-1)

Search for Circulating Tumour Cells in the Blood and/or Cerebrospinal Fluid in Patients With Recurrent Aggressive Meningiomas That Have Recurred: Proof-of-concept Study

The goal of the clinical trial is to assess the presence of circulating tumor cells (CTCs) in the blood and/or cerebrospinal fluid (CSF) of patients with aggressive recurrent meningiomas.

Study Overview

• Status: Not yet recruiting
• Conditions: Meningioma
• Intervention / Treatment: Other: Blood sampling; Other: Lumbar puncture

Detailed Description

Meningiomas are the most common intracranial tumours. In 80% of cases, they are benign (grade I) and have an indolent growth profile. These tumours are monitored radiologically and clinically using magnetic resonance imaging (MRI), or treated by surgical excision, with good results. However, 20% of them manifest as more aggressive tumours, leading to significant morbidity, either due to symptoms related to their natural history or complications related to treatment. These aggressive meningiomas represent a challenge both in terms of prognosis assessment and treatment selection.

Meningiomas are generally diagnosed using a CT or MRI scan of the brain or spinal cord with contrast injection. However, a definitive diagnosis remains dependent on histopathology, which is used to decide on the treatment sequence.

Recently, liquid biopsy has proven useful in the diagnosis and monitoring of many cancerous conditions. However, no studies have been conducted on the presence of circulating tumour cells (CTCs) in meningiomas. Although these tumours are intracranial, they develop outside the blood-brain barrier, so it is likely that cells are detectable in the blood and cerebrospinal fluid (CSF).

The use of blood markers could enable non-invasive confirmation of the diagnosis when a meningioma is detected by imaging, as well as assessment of the risk of recurrence in the post-operative period.

The BIOLIMEN-1 study is a pilot study aimed at developing and validating this concept.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julien BOETTO, Dr; Phone Number: +33 0467337488; Email: j-boetto@chu-montpellier.fr

Study Locations

• France
  • France
    • Montpellier, France, France, 34295
      • CHU de Montpellier
      • Contact: Julien BOETTO, Dr; Phone Number: +33 0467337488; Email: j-boetto@chu-montpellier.fr
      • Principal Investigator: Julien BOETTO, Dr

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Over 18 years of age
• Operated on for a grade 2 or 3 meningioma at Montpellier University Hospital between 2015 and 2024
• Tumour expressing SSTR2A on the initial surgical specimen
• Clinical and/or radiological recurrence as determined by MRI imaging (progression of a residual lesion OR appearance of a new lesion consistent with a meningioma at the surgical site or elsewhere)

Exclusion Criteria:

• Other active ongoing cancer
• Contraindications to lumbar puncture:
• Intracranial hypertension with meningioma exerting a mass effect and obstruction of the cerebrospinal fluid (CSF) pathway/risk of trans-tentorial or amygdalar herniation
• Blood clotting disorder with risk of haematoma at the puncture site (anticoagulant treatment at therapeutic dose or antiplatelet therapy, thrombocytopenia or thrombopathy)
• Infection at the puncture site
• Pregnant or breastfeeding women (Article L.1121-5 of the French Public Health Code)
• Persons deprived of their liberty by judicial or administrative decision (Article L.1121-6 of the French Public Health Code)
• Persons who are subject to legal protection measures or who are unable to express their consent (guardianship, curatorship, judicial protection; Article L.1121-8 of the French Public Health Code)
• Not affiliated with a social security scheme or beneficiary of such a scheme (Article L.1121-8-1 of the French Public Health Code)
• Persons participating in another study that includes an ongoing exclusion period (Article L.1121-12 of the French Public Health Code)
• Failure to obtain written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental arm

Other: Blood sampling; At the diagnosis of meningioma recurrence: a blood sample of 28 mL of whole blood (i.e., 4 EDTA tubes of 7 mL each) and at the end of meningioma recurrence treatment: a blood sample of 28 mL of whole blood (i.e., 4 EDTA tubes of 7 mL each) will be collect.; Other: Lumbar puncture; At the time of diagnosis of meningioma recurrence :a cerebrospinal fluid (CSF) sample obtained by lumbar puncture, in the absence of contraindications verified by the investigator, collected in one dry tube of 4 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of circulating tumour cells (CTC) in blood	i.e the proportion of patients with at least one CTC in the venous blood sample	Before treatment of meningioma recurrence and at the end of meningioma recurrence treatment on Day 90 (± 15 days) in case of radiotherapy, or on Day 1 post-surgery in case of surgery
Detection rate of circulating tumour cells (CTC) in cerebrospinal fluid	i.e the proportion of patients with at least one CTC in the cerebrospinal fluid	Before treatment of meningioma recurrence

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of circulating tumour cells (CTC) in blood	i.e defined as the presence of at least one CTC in the blood sample	Before treatment of meningioma recurrence and at the end of meningioma recurrence treatment on Day 90 (± 15 days) in case of radiotherapy, or on Day 1 post-surgery in case of surgery
Presence of circulating tumour cells (CTC) in cerebrospinal fluid	i.e defined as the presence of at least one CTC in the cerebrospinal fluid sample	Before treatment of meningioma recurrence
Number of circulating tumour cells (CTC) in blood		Before treatment of meningioma recurrence and at the end of meningioma recurrence treatment on Day 90 (± 15 days) in case of radiotherapy, or on Day 1 post-surgery in case of surgery
Number of circulating tumour cells (CTC) in cerebrospinal fluid		Before treatment of meningioma recurrence

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; Therapy; Liquid Biopsy; Circulating tumor cells; Neoplasm Recurrence, Local; Meningioma diagnosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplastic Processes; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Neoplasm Metastasis; Pathological Conditions, Signs and Symptoms; Meningioma; Neoplastic Cells, Circulating; Neoplasm Recurrence, Local; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Biopsy; Diagnostic Techniques, Neurological; Spinal Puncture; Blood Specimen Collection
• Other Study ID Numbers: RECHMPL24_0381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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