Cancer types
  • Neuro-oncology
Title of study
PREselection of patients at risk for COgnitive DEcline after Radiotherapy using advanced MRI
Version Number
Approval Date 
1.3, 08-02-2021
Short Title
PRECODE-MRI
Study site
Principle Investigator
D. Eekers
Investigator Maastro
D. Eekers
Sponsor
MAASTRO
Trial registry
Objectives 

To investigate the dose-response relation between cognitive decline and radiotherapy dose for patients with a benign meningioma WHO I.

Primary Endpoint 

Correlation between the delta cognitive failure score (baseline vs 2 years) and radiotherapy dose in cognition related brain regions (supratentorial brain, hippocampus left/right and anterior/posterior, cerebellum anterior/posterior)

Secondary Endpoints 

– Correlation between baseline imaging (advanced MRI sequence) and patient specific parameters (e.g. baseline cognitive status, age, Karnofsky index (KPS), co-morbidity, alcohol consumption, smoking, medication)
– RT-induced cognitive decline measured with extensive cognitive testing; specifically looking at: Hopkins verbal learning (HVLT), Trail making test A & B, COWA, 15 WLT, Digitspan, LDST, Stroop, Fluency, Dutch wordlist/NLV (IQ-score)
– Correlation of advanced MRI and treatment/dose parameters to PROMS; EQ/5D, QLQ/C30, QLQ/BN20, Cognitive Failure questionnaire (CFQ) , Multidimentional Fatigue Index (MVI/20)
– Identification of radiation susceptibility of individual anatomical and functional central nervous system (CNS) organs (e.g. (hippocampi, frontal lobe, cerebellum, brain) for radiation damage;
– Sensitivity of additional extensive neurocognitive tests. – Correlation of advanced MRI and treatment/dose parameters and radiotherapy modality (photon vs proton).