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NCT Number: NCT07398170

Search for Circulating Tumour Cells in the Blood and/or Cerebrospinal Fluid in Patients With Recurrent Aggressive Meningiomas: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier

Montpellier, France, 34295

Location status: Recruiting

Location contact

Julien BOETTO, Dr

CONTACT

[email protected]

0467337488 ext. +33

Julien BOETTO, Dr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Blood sampling

Other

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.

Lumbar puncture

Other

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.

Primary outcomes

  1. Detection rate of circulating tumour cells (CTC) in blood

    Time frame: 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

    i.e the proportion of patients with at least one CTC in the venous blood sample

  2. Detection rate of circulating tumour cells (CTC) in cerebrospinal fluid

    Time frame: Before treatment of meningioma recurrence

    i.e the proportion of patients with at least one CTC in the cerebrospinal fluid

Secondary outcomes

  1. Presence of circulating tumour cells (CTC) in blood

    Time frame: 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

    i.e defined as the presence of at least one CTC in the blood sample

  2. Presence of circulating tumour cells (CTC) in cerebrospinal fluid

    Time frame: Before treatment of meningioma recurrence

    i.e defined as the presence of at least one CTC in the cerebrospinal fluid sample

  3. Number of circulating tumour cells (CTC) in blood

    Time frame: 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

  4. Number of circulating tumour cells (CTC) in cerebrospinal fluid

    Time frame: Before treatment of meningioma recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Julien BOETTO, Dr

CONTACT

[email protected]

0467337488 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: BIOLIMEN-1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Jul 14, 2026

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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