Plasma Extracellular Vesicles in Meningioma Patients (MOLI)

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: Meningioma
• Intervention / Treatment: Other: Explorative biomarker study

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

• Study Contact: Name: Adriane Lentz-Hommertgen, PhD; Phone Number: 8201 +496221 56; Email: adriane.lentz-hommertgen@med.uni-heidelberg.de
• Study Contact Backup: Name: Max Deng, MD; Phone Number: 8201 +496221 56; Email: maximilian.deng@med.uni-heidelberg.de

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	number of patients without tumor progress	until 2 years follwoing radiotherapy
overall survival	number of alive patients	until 2 years follwoing radiotherapy

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Study record dates

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: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Meningioma
• 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