Identifying Patients at Risk for Cognitive Decline After Radiotherapy for Meningioma
PREselection of Patients at Risk for COgnitive DEcline After Radiotherapy Using Advanced MRI
Maastricht Radiation Oncology · NCT04638478
This study is trying to find out which patients with meningioma might have memory or thinking problems after receiving radiation treatment, using advanced brain scans to help protect their cognitive health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 67 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht Radiation Oncology (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT04638478 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify patients with meningioma who are at risk for cognitive decline following radiotherapy using advanced MRI techniques. It focuses on understanding the impact of high-dose radiotherapy on neurocognitive function, particularly in patients with a good prognosis. By analyzing brain areas affected by radiation, the study seeks to develop strategies to preserve cognitive function in these patients. Participants will undergo neuropsychological testing and imaging to assess their cognitive health over time.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of WHO grade I meningioma and a Karnofsky Performance Score of 70 or above.
Not a fit: Patients who have undergone prior cranial radiotherapy or have severe medical conditions that interfere with follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help in developing targeted interventions to preserve cognitive function in patients undergoing radiotherapy for meningioma.
How similar studies have performed: While the approach of using advanced MRI to assess cognitive decline post-radiotherapy is innovative, similar studies have shown varying degrees of success in understanding cognitive impacts of cancer treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meningioma WHO I, grading based on pathology or radiological features * Age ≥ 18 years. * Karnofsky Performance Score 70 or above. * Ability to comply with the protocol, including neuropsychological testing and imaging. * Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician. * Written informed consent. Exclusion Criteria: * Resection meningioma \< 3mnd * Age \< 18 years * Pregnancy * Any prior cranial radiotherapy * Any prior chemotherapy in the last 5 years * Contra-indication for MR imaging (i.e. metal implants, claustrophobia) * Any other serious medical condition that could interfere with follow-up. * Severe aphasia or language barrier interfering with assessing endpoints (i.e. completion of questionnaires or neurocognitive performance)
Where this trial is running
Maastricht, Limburg
- Maastricht Radiation Oncology — Maastricht, Limburg, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Danielle Eekers — Maastro Clinic, The Netherlands
- Study coordinator: Karen Zegers
- Email: karen.zegers@maastro.nl
- Phone: +31884455600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Meningioma, Radiotherapy, MRI, Neurocognition