Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05727605

Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-05-08

120

Participants Needed

3

Research Sites

207 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

U

University Hospital, Ghent

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this multicenter prospective longitudinal study is to study the long-term impact of multimodal treatment (chemotherapy, radiotherapy and surgery) in adult brain and base of skull tumors on neurocognitive functioning. All included patients will complete a self-report inventory (subjective cognitive functioning, QoL, confounders), a cognitive test battery, an advanced MR at multiple timepoints. Moreover, toxicity will be scored according to the CTCAEv5.0 in these patients over time.

CONDITIONS

Official Title

Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (18 years or older at diagnosis) with a primary brain or base of skull tumor
  • Patients eligible for conventionally fractionated radiotherapy (photon or proton irradiation)
Not Eligible

You will not qualify if you...

  • Tumors with poor prognosis such as incompletely resected IDH-wild-type glioma
  • Completely resected IDH-wild-type and MGMT-promotor unmethylated glioma
  • Grade III meningioma
  • H3K27M+ midline glioma
  • Tumors requiring craniospinal or whole ventricular irradiation
  • Hypofractionated or stereotactic radiation (fraction size greater than 2 Gy)
  • Inability to perform cognitive tests or self-reports due to motor, sensory, or language difficulties
  • Documented mental retardation before diagnosis
  • Pre-existing psychiatric diagnoses causing cognitive deficits (e.g., psychoses, autism, learning disorders)
  • Previous relapse treated by chemotherapy and/or radiation therapy
  • Genetic syndromes such as Down syndrome
  • Unable to undergo MRI due to claustrophobia or metallic implants like pacemaker, ICD, or neurostimulator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

University Hospitals Ghent

Ghent, Belgium

Actively Recruiting

2

UZ Leuven

Leuven, Belgium

Actively Recruiting

3

Gasthuis Zusters Antwerpen

Wilrijk, Belgium

Actively Recruiting

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Research Team

L

Laurien De Roeck, MD

CONTACT

M

Maarten Lambrecht, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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