CClinicalTrials.gg
RecruitingNCT07398170BIOLIMEN-1Updated Jul 14, 2026

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

An interventional study of Blood sampling and Lumbar puncture in Meningioma, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Meningioma

Keywords

  • Meningioma diagnosis
  • Circulating tumor cells
  • Liquid Biopsy
  • Neoplasm Recurrence, Local
  • Therapy
  • Biomarkers
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Experimental arm

    Other: Blood sampling · Other: Lumbar puncture

Interventions

  • OtherBlood 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.

  • OtherLumbar 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.

05

What researchers measure

Primary outcomes

  1. 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

    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

  2. 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

    Time frame: Before treatment of meningioma recurrence

Secondary outcomes

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

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

    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

  2. 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

    Time frame: Before treatment of meningioma recurrence

  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

06

Study locations

1 of 1 sites recruiting
  • CHU de Montpellier
    Montpellier, France 34295, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07398170
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Feb 9, 2026
Start date
Jul 13, 2026
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jul 14, 2026

Study contacts

Julien BOETTO, Dr
Contact
j-boetto@chu-montpellier.fr
0467337488 ext. +33

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion