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PREselection of Patients at Risk for COgnitive DEcline After Radiotherapy Using Advanced MRI

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: May 1, 2026 to Dec 31, 2028 Trial status: Recruiting to Active, Not Recruiting · Site details revisedv9 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
  2. Notable Primary completion date: Apr 8, 2025 to May 1, 2026 Completion date: Apr 8, 2025 to May 1, 2029v8 Show 1 more changeShow less
    • Completion date: Apr 8, 2025 to May 1, 2029
  3. Minor 2 versions Re-verified since Nov 9, 2023, no change to tracked fieldsv6-v7
  4. Minor Eligibility criteria expanded, about 5 wordsv5 See this version in full on ClinicalTrials.gov ↗
  5. Minor Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting Enrollment target: 60 to 67 · Study sites: 0 to 1 · Primary and study completion dates: Apr 1, 2025 to Apr 8, 2025 · 1 morev3 Show 4 more changesShow less
    • Enrollment target: 60 to 67
    • Study sites: 0 to 1
    • Primary and study completion dates: Apr 1, 2025 to Apr 8, 2025
    • Start date changed from estimate of Apr 1, 2021 to Apr 8, 2021
  2. Notable Start date: Jan 1, 2021 to Apr 1, 2021 Primary and study completion dates: Jan 1, 2025 to Apr 1, 2025v2 Show 1 more changeShow less
    • Primary and study completion dates: Jan 1, 2025 to Apr 1, 2025
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Meningioma are slow growing and frequently occurring intracranial tumors, responsible for 33% of all asymptomatic intracranial tumors and 13-26% of all symptomatic primary brain tumors. The 10-year survival rate is 72%. A variety of treatment options is available for symptomatic meningioma including surgical removal with or without radiotherapy or radiotherapy alone. These therapies can have negative impact on cerebral functioning. After high dose radiotherapy for primary or metastatic brain tumors 50-90% of \> 6 months' survivors develop irreversible disabling cognitive decline leading to premature loss of independence, reduced Quality of Life (QOL) as well as significant economic burden both at the individual as societal level. Especially for patients with a good prognosis like benign meningioma, maintaining neurocognitive function is crucial. Understanding the mechanisms underlying radiation induced cognitive decline is complex and which brain areas to spare are an important subject of research. Evaluation methods to assess cognitive function and predict cognitive decline are urgently needed, this will allow the development of optimized treatment strategies with the aim to preserve or even improve cognitive function in meningioma patients. Improvements in the field of neuroimaging techniques (i.e. advanced MRI techniques) have the possibility to identify areas susceptible to cognitive impairment. This allows in the future a more personalized radiation treatment by identifying patients at risk, by optimizing the radiotherapy dose to specific brain regions, that could eventually reduce or prevent, cognitive decline. Improvements in the field of radiotherapy for example by higher precision treatment such proton therapy have potential in obtaining these more individualized strategies.
Trial Details
NCT Number NCT04638478
Lead Sponsor Maastricht Radiation Oncology
Collaborators: Maastricht University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
Conditions Meningioma
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov