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PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glioblastoma

StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Notable Primary completion pushed from Jun 1, 2029 to Dec 1, 2030
    • Study completion pushed from Jun 1, 2030 to Dec 1, 2031
    v8
  2. Minor Secondary endpoints revised (3)v7
  3. Notable Primary completion date: Jun 1, 2028 to Jun 1, 2029
    • Start date: Dec 1, 2025 to Dec 1, 2026
    • Study completion date: Jun 1, 2029 to Jun 1, 2030
    v6
  4. Notable Primary completion date: Dec 1, 2027 to Jun 1, 2028
    • Start date: Jun 1, 2025 to Dec 1, 2025
    • Study completion date: Dec 1, 2028 to Jun 1, 2029
    v5
  5. Minor Site contact updatedv4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Primary completion date: Dec 1, 2026 to Dec 1, 2027
    • Start date: Dec 1, 2024 to Jun 1, 2025
    • Study completion date: Dec 1, 2027 to Dec 1, 2028
    • Site contact updated
    v3
  2. Notable Primary completion date: Jun 1, 2026 to Dec 1, 2026
    • Start date: Jun 1, 2024 to Dec 1, 2024
    • Study completion date: Jun 1, 2027 to Dec 1, 2027
    • Secondary endpoints: details revised at 1 of 3 entries
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and tumor tissue. CEST MRI is a technique that uses differences in the tissue environment, like protein concentration or intracellular pH, to generate contrast differences. CEST MRI may identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.
Trial Details
NCT Number NCT06448286
Lead Sponsor Jonsson Comprehensive Cancer Center
Conditions
(from sponsor)
Glioblastoma
Related terms Glioblastoma
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov