Plasma Extracellular Vesicles in Meningioma Patients (MOLI)

March 6, 2026 updated by: Juergen Debus, University Hospital Heidelberg

Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy

While surgical resection remains the primary treatment approach for symptomatic or growing meningiomas, radiotherapy represents an auspicious alternative in patients with meningiomas not safely amenable to surgery. Biopsies are often omitted in light of potential postoperative neurological deficits, resulting in a lack of histological grading and (molecular) risk stratification. In this prospective explorative biomarker study, extracellular vesicles in the bloodstream will be investigated in patients with macroscopic meningiomas to identify a biomarker for molecular risk stratification and disease monitoring.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In total, 60 patients with meningiomas and an indication of radiotherapy (RT) and macroscopic tumor on the planning MRI will be enrolled. Blood samples will be obtained before the start, during, and after radiotherapy, as well as during clinical follow-up every 6 months. Extracellular vesicles will be isolated from the blood samples, quantified and correlated with the clinical treatment response or progression. Further, nanopore sequencing-based DNA methylation profiles of plasma EV-DNA will be generated for methylation-based meningioma classification.

This study will explore the dynamic of plasma EVs in meningioma patients under/after radiotherapy, with the objective of identifying potential biomarkers of (early) tumor progression. DNA methylation profiling of plasma EVs in meningioma patients may enable molecular risk stratification, facilitating a molecularly-guided clinical management in meningioma patients in the future.

Study Type

Interventional

Enrollment (Estimated)

60

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

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Recruiting
        • University Hospital of Heidelberg, Radiation Oncology
        • Principal Investigator:
          • Jürrgen Debus, MD PHD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • confirmed meningioma (histologically or MRI/DOTATOC-PET CT)
  • macroscopic tumor in MRI (either as definitive RT, or following subtotal resection or relapse)
  • indication for radiotherapy
  • completed wound healing after surgical intervention)
  • Alter ≥ 18 Jahre
  • Karnofsky Performance Score ≥ 60%
  • written informed consent
  • ability of subject to understand character and individual consequences of the trial
  • adequate contraception for women of childbearing potential

Exclusion Criteria:

  • previous or known tumor diseases < 5 years ago
  • previous (cerebral) radiotherapy
  • simultaneous chemo/immunotherapy
  • evidence that the patient cannot adhere to the study protocol (e.g., non-compliance)
  • the refusal of patients to participate in the study
  • participation in another clinical study or observation period in a competing trial

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Plasma extracellular vesicles in meningioma patients following radiotherapy as liquid biopsy
Explorative biomarker study
Other: Explorative biomarker study
Analysis of blood biomarker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dynamic of plasma EVs
Time Frame: until 2 years follwoing radiotherapy
Change of amount of plasma EVs in meningioma patients compared to sample taken before radiotherapy
until 2 years follwoing radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progession-fee survival
Time Frame: until 2 years follwoing radiotherapy
number of patients without tumor progress
until 2 years follwoing radiotherapy
overall survival
Time Frame: until 2 years follwoing radiotherapy
number of alive patients
until 2 years follwoing radiotherapy

Collaborators and Investigators

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

Sponsor

University Hospital Heidelberg

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 (Actual)

November 1, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADONK-MOLI-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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