Status:

RECRUITING

Plasma Extracellular Vesicles in Meningioma Patients

Lead Sponsor:

University Hospital Heidelberg

Conditions:

Meningioma

Eligibility:

All Genders

Phase:

NA

Brief 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 amenab...

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 a...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06104930

Start Date

November 1 2023

End Date

February 1 2026

Last Update

November 18 2023

Active Locations (1)

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1

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, Germany, 69120