MeningiomaBIOLIMEN-1NCT07398170
Search for Circulating Tumour Cells in the Blood and/or Cerebrospinal Fluid in Patients With Recurrent Aggressive Meningiomas: Proof-of-concept Study
A study testing Blood sampling and Lumbar puncture in people with Meningioma, run by University Hospital, Montpellier at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- Blood sampling and Lumbar puncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier
Montpellier, France, 34295
Julien BOETTO, Dr, 0467337488 ext. +33, j-boetto@chu-montpellier.fr
Julien BOETTO, Dr
About this study
Official 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
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.
- Conditions
- Meningioma
- Being tested
- Blood sampling, Lumbar puncture
- Keywords
- Meningioma diagnosis, Circulating tumor cells, Liquid Biopsy, Neoplasm Recurrence, Local, Therapy, Biomarkers
- Medical subject headings
- Meningioma, Neoplastic Cells, Circulating, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
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 punctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Other: Blood sampling; Other: Lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Before treatment of meningioma recurrence
Secondary outcomes (4)
Presence of circulating tumour cells (CTC) in blood
i.e defined as the presence of at least one CTC in the blood sample
Measured: 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
Measured: Before treatment of meningioma recurrence
Number of circulating tumour cells (CTC) in blood
Measured: 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
Measured: Before treatment of meningioma recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start13 Jul 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398170
- Sponsor's protocol ID
- RECHMPL24_0381
- Acronym
- BIOLIMEN-1
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07398170
- Acronym / sponsor ID
- BIOLIMEN-1 / RECHMPL24_0381
- Conditions
- Meningioma
- Keywords
- Meningioma diagnosis, Circulating tumor cells, Liquid Biopsy, Neoplasm Recurrence, Local, Therapy, Biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Blood sampling, Other: Lumbar puncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingAt 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 | Experimental arm |
| Lumbar punctureAt 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. | Other | Experimental arm |
Primary outcome
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
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
4 secondary outcomes
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
Presence of circulating tumour cells (CTC) in cerebrospinal fluid
Time frame: Before treatment of meningioma recurrence
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
Number of circulating tumour cells (CTC) in cerebrospinal fluid
Time frame: Before treatment of meningioma recurrence
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Lumbar puncture in people with Meningioma, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien BOETTO, Dr (0467337488 ext. +33, j-boetto@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.