MeningiomaPIVIMNCT07428213
Measurement of PSMA Expression in Vivo in Recurrent Meningiomas by PET Imaging: a Preliminary Study to a Therapeutic Trial Using Radioligand Therapy (RLT)
A study testing PET PSMA in people with Meningioma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Meningioma is the most common intracerebral tumor in adults. Conventional treatment includes surgery and external beam radiation therapy. However, when multiple surgeries and radiation therapy sessions fail to control tumor progression, no standard treatment is adopted. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Meningioma
- What is being tested?
- PET PSMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2026to Mar 2028
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (≥18 years old),
- Beneficiary or entitled to a social security scheme
- Patient who has agreed to participate in the study and signed written informed consent
- Patients with histologically proven meningioma that has recurred after surgery and/or radiotherapy and/or systemic treatment
Who cannot join
- Contraindication to [18F]PSMA PET scan: hypersensitivity to the active substance or to any of the excipients (ethanol, sodium chloride injection, and sodium ascorbate), according to the SPC sheet (https://www.ema.europa.eu/fr/documents/product-information/pylclari-epar-product-information_fr.pdf).
- Antiangiogenic treatment within 60 days prior to inclusion
- Impossible to follow-up for 12 months
- Pregnant, parturient, or breastfeeding women. A pregnancy test will be performed before inclusion for women of childbearing age within 48 hours prior to the examination. -Individuals deprived of their liberty by a judicial or administrative decision
- Individuals receiving psychiatric care
- Individuals admitted to a health or social care facility for purposes other than research
- Adults subject to a legal protection measure (guardianship, curatorship)
- Subjects participating in another interventional research study that includes an exclusion period still in effect at the time of inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
MANSUY Adeline contact
France1 site
Hôpital Louis Pradel
Bron, 69500
FLAUS ANTHIME, Dr, 04 72 35 69 99, anthime.flaus@chu-lyon.fr
About this study
Meningioma is the most common intracerebral tumor in adults. Conventional treatment includes surgery and external beam radiation therapy. However, when multiple surgeries and radiation therapy sessions fail to control tumor progression, no standard treatment is adopted. Therefore, refractory multi-recurrent meningiomas remain an unmet medical need and warrant the search for new therapies.
In this respect, radioligand therapy (RLT) with LUTATHERA is used in the context of early compassionate access. RLT is based on the combination of a vector molecule directed specifically at a target (here the somatostatin receptors), with a radioactive isotope emitting particles destroying the targeted cells, and possibly their neighbors (here Lutetium 177). This treatment is indicated only if positron emission tomography (PET) imaging of somatostatin receptors is positive, excluding patients. In terms of efficacy, this treatment allows disease control in recurrences for low grade (grade 1) but has an insufficient effect in most aggressive meningiomas (grade 2, 3).
Read more
RLT targeting the prostate specific membrane antigen (PSMA) prolongs the survival of patients with metastatic prostate cancer that significantly expresses PSMA, presenting a tumor signal higher than the hepatic signal in PET with PSMA ligands. PSMA is a transmembrane receptor, overexpressed in tumor cells and endothelial cells of neovascularization of various solid tumors. Initial results in immunohistochemistry (IHC) suggest that PSMA is expressed by neovascularization of meningiomas in a manner correlated with grades and recurrence. This is partly explained by the highly vascular nature of these lesions and has been iconographed by clinical cases in PSMA PET confirming in vivo an overexpression of PSMA. This overexpression of PSMA within meningiomas could offer a therapeutic alternative in RLT in patients where Lutathera is not suitable. However, there is no systematic study of the frequency and intensity of PSMA expression by PSMA ligand PET in recurrent meningiomas.
The aim of the study is to evaluate the frequency of significant in vivo PSMA expression in recurrent meningiomas via PSMA ligand PET. We consider that at least 50% of recurrent meningiomas should have a significant level of PSMA expression in PSMA ligand PET to justify a therapeutic RLT trial targeting PSMA. In addition, as an exploratory study, in the subgroup of operated patients, an IHC analysis will be performed to explore the association between the PET signal and PSMA expression and confirm the specificity of the signal.
- Conditions
- Meningioma
- Being tested
- PET PSMA
- Keywords
- Recurrent meningioma, RLT, PET PSMA
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET PSMAOther
PET PSMA ; 1 by subject before surgery
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with recurrent meningioma | Experimental | Adult patients with recurrent meningioma Receives: Other: PET PSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant expression of PSMA
To estimate the percentage of patients with meningioma with significant PSMA expression in PSMA ligand PET
Measured: 1 month
Secondary outcomes (6)
Significant expression of PSMA and grade of meningioma in anatomopathological analysis
To evaluate the percentage of patients with significant PSMA expression in PSMA ligand PET scans as a function of the grade of meningioma defined by anatomopathological analysis.
Measured: 3 months after the surgery
Measurement of PSMA expression at 120 min and somatostatin receptors in PET quantified in SUV units on the PET console
To evaluate the association between PSMA expression measurement in meningioma PSMA ligand PET and somatostatin receptor expression measurement in [68Ga]DOTATOC PET in the subgroup of patients undergoing both examinations.
Measured: 1 month
Measurement of PSMA PET expression quantified in SUV units at 120 min on the Siemens PET console and tumor growth measurement measured by MRI (% variation in tumor volume between the last two MRIs)
To evaluate the association between PSMA expression measurement in meningioma PSMA ligand PET and tumor growth measurement measured by MRI in the subgroup of patients undergoing both examinations.
Measured: 1 month
Measurement of PSMA expression in PET is quantified in SUV units at acquisitions at different time points
To evaluate the washout rate of the PSMA PET tracer by performing multiple acquisitions at different time points in the subgroup of patients performing the different PET acquisitions.
Measured: 1 month
PSMA tracer fixation measurements in PET at different time points in SUV (at 120, 210 and 300 minutes) and the tumor volume
Estimate the mean dose of Lu-177-labeled PSMA deposited in the tumor from PSMA ligand PET imaging in the subgroup of patients performing the different PET acquisitions.
Measured: 1 month
Measurement of PSMA expression in PET is quantified in units of Standardized uptake value (SUV) at 120 min and the measurement of PSMA expression in immunohistochemistry on the surgical specimen
Evaluate the association between the measurement of PSMA expression in PSMA ligand PET of meningiomas and the immunohistochemical measurement of PSMA expression on the surgical specimen in the subgroup of operated patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (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 Hospices Civils de LyonThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428213
- Sponsor's protocol ID
- 69HCL24_1208
- Other IDs
- 2026-A00403-48
- Acronym
- PIVIM
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of PSMA Expression in Vivo in Recurrent Meningiomas by PET Imaging: a Preliminary Study to a Therapeutic Trial Using Radioligand Therapy (RLT)
- ClinicalTrials.gov ID
- NCT07428213
- Acronym / sponsor ID
- PIVIM / 69HCL24_1208
- Conditions
- Meningioma
- Keywords
- Recurrent meningioma, RLT, PET PSMA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 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.
Meningioma is the most common intracerebral tumor in adults. Conventional treatment includes surgery and external beam radiation therapy. However, when multiple surgeries and radiation therapy sessions fail to control tumor progression, no standard treatment is adopted. Therefore, refractory multi-recurrent meningiomas remain an unmet medical need and warrant the search for new therapies.
In this respect, radioligand therapy (RLT) with LUTATHERA is used in the context of early compassionate access. RLT is based on the combination of a vector molecule directed specifically at a target (here the somatostatin receptors), with a radioactive isotope emitting particles destroying the targeted cells, and possibly their neighbors (here Lutetium 177). This treatment is indicated only if positron emission tomography (PET) imaging of somatostatin receptors is positive, excluding patients. In terms of efficacy, this treatment allows disease control in recurrences for low grade (grade 1) but has an insufficient effect in most aggressive meningiomas (grade 2, 3).
RLT targeting the prostate specific membrane antigen (PSMA) prolongs the survival of patients with metastatic prostate cancer that significantly expresses PSMA, presenting a tumor signal higher than the hepatic signal in PET with PSMA ligands. PSMA is a transmembrane receptor, overexpressed in tumor cells and endothelial cells of neovascularization of various solid tumors. Initial results in immunohistochemistry (IHC) suggest that PSMA is expressed by neovascularization of meningiomas in a manner correlated with grades and recurrence. This is partly explained by the highly vascular nature of these lesions and has been iconographed by clinical cases in PSMA PET confirming in vivo an overexpression of PSMA. This overexpression of PSMA within meningiomas could offer a therapeutic alternative in RLT in patients where Lutathera is not suitable. However, there is no systematic study of the frequency and intensity of PSMA expression by PSMA ligand PET in recurrent meningiomas.
The aim of the study is to evaluate the frequency of significant in vivo PSMA expression in recurrent meningiomas via PSMA ligand PET. We consider that at least 50% of recurrent meningiomas should have a significant level of PSMA expression in PSMA ligand PET to justify a therapeutic RLT trial targeting PSMA. In addition, as an exploratory study, in the subgroup of operated patients, an IHC analysis will be performed to explore the association between the PET signal and PSMA expression and confirm the specificity of the signal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with recurrent meningioma | Experimental | Other: PET PSMAAdult patients with recurrent meningioma |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient (≥18 years old),
- Beneficiary or entitled to a social security scheme
- Patient who has agreed to participate in the study and signed written informed consent
- Patients with histologically proven meningioma that has recurred after surgery and/or radiotherapy and/or systemic treatment
Key exclusion criteria (8 listed)
- Contraindication to [18F]PSMA PET scan: hypersensitivity to the active substance or to any of the excipients (ethanol, sodium chloride injection, and sodium ascorbate), according to the SPC sheet (https://www.ema.europa.eu/fr/documents/product-information/pylclari-epar-product-information_fr.pdf).
- Antiangiogenic treatment within 60 days prior to inclusion
- Impossible to follow-up for 12 months
- Pregnant, parturient, or breastfeeding women. A pregnancy test will be performed before inclusion for women of childbearing age within 48 hours prior to the examination. -Individuals deprived of their liberty by a judicial or administrative decision
- Individuals receiving psychiatric care
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 |
|---|---|---|
| PET PSMAPET PSMA ; 1 by subject before surgery | Other | Adult patients with recurrent meningioma |
Primary outcome
Significant expression of PSMA
Time frame: 1 month
To estimate the percentage of patients with meningioma with significant PSMA expression in PSMA ligand PET
6 secondary outcomes
Significant expression of PSMA and grade of meningioma in anatomopathological analysis
Time frame: 3 months after the surgery
Measurement of PSMA expression at 120 min and somatostatin receptors in PET quantified in SUV units on the PET console
Time frame: 1 month
Measurement of PSMA PET expression quantified in SUV units at 120 min on the Siemens PET console and tumor growth measurement measured by MRI (% variation in tumor volume between the last two MRIs)
Time frame: 1 month
Measurement of PSMA expression in PET is quantified in SUV units at acquisitions at different time points
Time frame: 1 month
PSMA tracer fixation measurements in PET at different time points in SUV (at 120, 210 and 300 minutes) and the tumor volume
Time frame: 1 month
Measurement of PSMA expression in PET is quantified in units of Standardized uptake value (SUV) at 120 min and the measurement of PSMA expression in immunohistochemistry on the surgical specimen
Time frame: 3 months
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 23 Feb 2026.
Related trials for Meningioma
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 2
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
Intracranial Meningioma, Recurrent Meningioma
Active, not recruitingPhase 1
Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas
Meningioma
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingPhase 2
A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma
Meningioma
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.
MANSUY Adeline contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET PSMA in people with Meningioma, run by Hospices Civils de Lyon 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 8 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: opening soon, as of the sponsor's last update on 23 Feb 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 FLAUS ANTHIME, Dr (04 72 35 69 99, anthime.flaus@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant expression of PSMA (time frame: 1 month). 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 23 Feb 2026.