LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)
The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with newly diagnosed gliomas.
Conditions:
🦠 Glioma 🦠 Glioblastoma 🦠 Brain Tumor
🗓️ Study Start (Actual) 20 February 2021
🗓️ Primary Completion (Estimated) February 2025
✅ Study Completion (Estimated) December 2027
👥 Enrollment (Estimated) 32
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baltimore, Maryland, United States
📍 Baltimore, Maryland, United States
📍 Bel Air, Maryland, United States
📍 Columbia, Maryland, United States
📍 Glen Burnie, Maryland, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Patients with radiographic evidence of suggestive of a primary high-grade glioma
    • 2. Brain MRI with contrast demonstrates an enhancing mass within 60 days prior to registration. Patient must be deemed a candidate for LITT from MRI by Neurosurgery in order to be eligible.
    • 3. History and physical including neurological exam within 30 days prior to registration
    • 4. Karnofsky performance status ≥50% within 30 days prior to registration
    • 5. Age ≥ 18 years old
    • 6. Patients must have signed an approved informed consent
    • 7. Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.
    • 8. Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.

    Exclusion Criteria:

    • 1. Patients that are not surgical candidates for stereotactic biopsy or laser ablation
    • 2. Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
    • * History or presence of serious uncontrolled ventricular or significant arrhythmias.
    • * Any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism
    • 3. Infratentorial tumor or evidence of leptomeningeal spread
    • 4. Inability to undergo a MRI
    • 5. Pregnant or breast-feeding women
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 4 January 2021
  • First Submitted that Met QC Criteria 6 January 2021
  • First Posted 7 January 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 March 2024
  • Last Update Posted 6 March 2024
  • Last Verified March 2024