Plasma Extracellular Vesicles in Meningioma Patients

NCT06104930 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Heidelberg

Phase

Not applicable

Started

2023-11-01

Last updated

2026-03-10

Condition(s) studied

Meningioma

Investigational drug(s) / intervention(s)

Explorative biomarker study

Explorative biomarker study: Analysis of blood biomarker

Study summary

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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

dynamic of plasma EVs — until 2 years follwoing radiotherapy
Change of amount of plasma EVs in meningioma patients compared to sample taken before radiotherapy

Trial sites (1)

Facility	City	Region	Status
University Hospital of Heidelberg, Radiation Oncology	Heidelberg	Germany	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06104930 on ClinicalTrials.gov ↗ ← All trials in Germany