Measurement of PSMA Expression in Vivo in Recurrent Meningiomas by PET Imaging: a Preliminary Study to a Therapeutic Trial Using Radioligand Therapy (RLT)
PIVIM
2 other identifiers
interventional
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
February 23, 2026
February 1, 2026
2 years
February 17, 2026
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Significant expression of PSMA
To estimate the percentage of patients with meningioma with significant PSMA expression in PSMA ligand PET
1 month
Secondary Outcomes (6)
Significant expression of PSMA and grade of meningioma in anatomopathological analysis
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
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)
1 month
Measurement of PSMA expression in PET is quantified in SUV units at acquisitions at different time points
1 month
PSMA tracer fixation measurements in PET at different time points in SUV (at 120, 210 and 300 minutes) and the tumor volume
1 month
- +1 more secondary outcomes
Study Arms (1)
Adult patients with recurrent meningioma
EXPERIMENTALAdult patients with recurrent meningioma
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
- Impossible to follow-up for 12 months
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Louis Pradel
Bron, 69500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
MANSUY Adeline
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2026
First Posted
February 23, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02