Measurement of PSMA Expression in Vivo in Recurrent Meningiomas by PET Imaging: a Preliminary Study to a Therapeutic Trial Using Radioligand Therapy (RLT) (PIVIM)

February 17, 2026 updated by: Hospices Civils de Lyon

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: MANSUY Adeline

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adult patients with recurrent meningioma
Other: PET PSMA
PET PSMA ; 1 by subject before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant expression of PSMA
Time Frame: 1 month
To estimate the percentage of patients with meningioma with significant PSMA expression in PSMA ligand PET
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant expression of PSMA and grade of meningioma in anatomopathological analysis
Time Frame: 3 months after the surgery
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.
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
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.
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
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.
1 month
Measurement of PSMA expression in PET is quantified in SUV units at acquisitions at different time points
Time Frame: 1 month
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.
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
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.
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
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL24_1208
  • 2026-A00403-48 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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