Plasma Extracellular Vesicles in Meningioma Patients
Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy
University Hospital Heidelberg
60 participants
Nov 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria6
- 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
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Interventions
Analysis of blood biomarker
Locations(1)
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NCT06104930