Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05727605

Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors

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

120

Participants Needed

3

Research Sites

52 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

Researchers are investigating the long-term effects of multimodal treatment including chemotherapy, radiotherapy, and surgery on neurocognitive function in adults with primary brain and base of skull tumors. This study focuses on understanding how radiotherapy impacts cognitive skills such as memory, executive functioning, attention, and language, by linking radiation dose to brain areas vulnerable to damage. The goal is to develop predictive models for neurocognitive decline to aid future treatment planning. Participants will undergo detailed neurocognitive testing, complete self-report questionnaires on cognitive function and quality of life, and receive advanced MRI scans at multiple timepoints. Treatments include photon or proton radiotherapy. Assessments occur before radiotherapy, and then at 3 months, 12 months, and 24 months after radiotherapy. Toxicity and adverse effects will be monitored throughout the study using standardized scoring. During the study, patients will complete cognitive tests such as WAIS digit span, HVLT-R, and Stroop Color Word Test, alongside questionnaires like EORTC QLQ C30 & BN20, STAI, and BDI-II. MRI scans will assess structural and functional brain changes at baseline, 3 months, and 12 months post-radiotherapy. Researchers will measure changes in cognitive scores compared to baseline to evaluate neurocognitive decline and develop prediction models. Safety monitoring will continue until study completion, with total follow-up lasting up to 2 years after radiotherapy.

CONDITIONS

Brief 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 aged 18 years or older at diagnosis
  • Diagnosed with a primary brain or base of skull tumor
  • Suitable for conventionally fractionated radiotherapy (photon or proton therapy)
Not Eligible

You will not qualify if you...

  • Tumors with poor prognostic features such as incompletely resected IDH-wild-type glioma
  • Completely resected IDH-wild-type and MGMT-promotor unmethylated glioma
  • Grade III meningioma
  • H3K27M positive midline glioma
  • Tumors requiring craniospinal or whole ventricular irradiation
  • Hypofractionated or stereotactic radiation with fraction sizes greater than 2 Gy
  • Inability to complete cognitive tests or questionnaires due to motor/sensory deficits or insufficient Dutch language
  • Documented mental retardation before diagnosis
  • Pre-existing psychiatric diagnoses causing cognitive deficits
  • Previous relapse treated by chemotherapy or radiation
  • Genetic syndromes such as Down syndrome
  • Inability to undergo MRI due to claustrophobia or implanted devices like pacemaker, ICD, or neurostimulator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline period before radiotherapy

Participants undergo advanced MR imaging and neurocognitive testing before radiotherapy to assess baseline brain function and structure.

1 baseline visit (in-person)

Treatment

Duration - Duration of radiotherapy treatment

Participants receive conventionally fractionated radiotherapy (photon or proton therapy). Toxicity and adverse events are monitored during and after radiotherapy.

Visits during and at end of radiotherapy for toxicity scoring

Long-term Monitoring

Duration - Up to 2 years post-radiotherapy

Participants are followed longitudinally with neurocognitive assessments, questionnaires, and advanced MR imaging to monitor neurocognitive decline and brain changes after radiotherapy.

Visits at 3 months, 12 months, and 24 months post-radiotherapy

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

M

Maarten Lambrecht, MD PhD

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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