Development of MRF for Characterization of Brain Tumors After Radiotherapy

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 2026 → Jan 2027
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Record History

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  1. Minor Primary completion pushed from Sep 2026 to Jan 2027
    • Study completion pushed from Sep 2026 to Sep 2027
    • Eligibility criteria expanded, about 13 words
  2. Minor Eligibility criteria expanded, about 31 words
  3. Notable Enrollment increased: 60 → 90 participants
    • Trial arms changed: 5 → 6
    • Eligibility criteria expanded, about 70 words
    v12
  4. Notable Primary completion date: Dec 2025 to Sep 2026
    • Study completion date: Jun 2026 to Sep 2026
    v11
  5. Minor Primary completion date: Jun 30, 2025 to Dec 2025
    • Study completion date: Dec 31, 2025 to Jun 2026
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Enrollment target: 40 to 60v9 Show 4 more changesShow less
    • Primary endpoints: 5 to 6
    • Eligibility criteria expanded, about 107 words
    • Study description revised
    • Study arms: 3 to 5
  2. Minor Study sites: 1 to 2v8
  3. Minor Start date changed from estimate of Oct 1, 2024 to Oct 14, 2024v7
  4. Notable Start date: Sep 1, 2024 to Oct 1, 2024v6
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
  6. Notable Start date: Aug 1, 2024 to Sep 1, 2024v4
  7. Notable Start date: Jun 1, 2024 to Aug 1, 2024v3
  8. Notable Start date: Jan 1, 2024 to Jun 1, 2024v2
  1. Study First Submitted
  • 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.
The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, individuals with previously untreated tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study. The primary objectives of this study are: * To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage. * To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis. * To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.
Trial Details
NCT Number NCT06101069
Lead Sponsor Case Comprehensive Cancer Center
Collaborators: The Cleveland Clinic
Conditions
(from sponsor)
Brain Tumor, Brain Necrosis, Brain Metastases, Glioma
Related terms Brain Neoplasms, Glioma
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov