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Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma
This clinical trial constructs and tests a novel multinuclear metabolic magnetic resonance imaging (MRI) sequence in patients with glioma (brain tumor) that is newly diagnosed or has come back (recurrent). This trial aims to develop new diagnostic imaging technology that may bridge gaps between early detection and diagnosis, prognosis, and treatment in brain cancer.
Conditions:
🦠 Glioma 🦠 Malignant Glioma 🦠 Recurrent Glioma 🦠 Recurrent Malignant Glioma
🗓️ Study Start (Actual) 1 September 2021
🗓️ Primary Completion (Estimated) 10 September 2026
✅ Study Completion (Estimated) 10 September 2027
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * AIM 1: Healthy volunteers with no evidence of brain tumors or neurologic disease
    • * AIM 1: Age 18+
    • * AIM 2: Newly diagnosed or recurrent suspected or confirmed glioma (low or high grade)
    • * AIM 2: 10 IDH mutant and 10 IDH wild type gliomas
    • * AIM 2: Clinically indicated for resective surgery or biopsy
    • * AIM 2: Age 18+
    • * AIM 2: Tumor size \> 1x1x1 cm (measurable)
    • * AIM 3: Recurrent glioma enrolled in an immunotherapy trial or clinically indicated to receive immunotherapy including anti-PD1
    • * AIM 3: Age 18+

    Exclusion Criteria:

    • * AIM 1: Cannot safely perform an MRI
    • * AIM 1: Age \< 18
    • * AIM 2: Cannot safely perform an MRI or use of MRI contrast agents
    • * AIM 2: Age \< 18
    • * AIM 3: Cannot safely perform an MRI or use of MRI contrast agents
    • * AIM 3: Age \< 18
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 September 2021
  • First Submitted that Met QC Criteria 7 September 2021
  • First Posted 16 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 September 2023
  • Last Update Posted 29 September 2023
  • Last Verified September 2023
I'm interested ...!!