This is a research study to evaluate how well surgery (called brain laser interstitial thermal therapy) in combination with standard of care radiation therapy and temozolomide medication works in people newly diagnosed with Glioblastoma (a fast-growing brain tumor.

What we are studying

You are being asked to take part in this research study because it is either suspected that you may have or you have been recently diagnosed with a type of brain tumor called glioblastoma (GBM). You and your study doctor have decided that you are going to undergo chemotherapy and radiation treatments as is the standard of care for this type of brain tumor. In addition to chemotherapy and radiation treatments, your surgeon has also determined that you are a candidate for a surgical procedure to treat your brain tumor. This surgery is called brain laser interstitial thermal therapy (LITT). LITT is a minimally invasive (involve small incision(s) instead of large opening) surgery method currently being used in neurosurgical procedures for brain lesions or tumors. The purpose of this study is to see how brain LITT using the Monteris NeuroBlate® System in combination with chemotherapy and radiation treatments performs for subjects diagnosed with GBM. Up to 45 subjects will participate at up to 5 centers in the U.S., including approximately 9 subjects at this research site. If you decide to be in the study, you will be enrolled for approximately 24 months. You will be required to attend at least 19 study appointments. If you decide to participate in this study, the evaluations and procedures will take place during the following study visits or phases: 1. Baseline - routine medical tests will be performed and data will be collected to help determine/confirm your eligibility to continue participation in the study. 2. NeuroBlate® System Procedure - is a technology that uses precise, laser energy to destroy tumors or lesions in the brain, while limiting injury to healthy tissue. It uses light to heat and destroy unwanted cells. 3. Pre-Chemoradiation Therapy - MRI (must be performed 72 hours after NeuroBlate® System procedure), Medications Review, Physical Exam, Neurological Exam, KPS, Hematology Blood Test, Chemistry Blood Test, Adverse Event Assessment will be performed 4. Chemoradiation Therapy (at least 6 visits) - the first treatment of chemotherapy and radiation will occur 2-6 weeks after the NeuroBlate® System procedure 5. Maintenance Chemotherapy (at least 6 visits) - approximately 4 weeks after the last chemoradiation treatment, temozolomide will be administered every 28 days for a total of 6 cycles (visits) 6. Follow-up (total of 4 visits) - after all study treatments have been completed, follow-up visits will be completed at 3, 6, 9, and 12 months.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Must have/be:
    • Stable cardiovascular and pulmonary health status
    • Single enhancing lesion that is >1 cm
  • But < 4 cm in cross-sectional dimension; willing to provide informed consent Must not have/be:
    • Seizures or the requirement of escalation (or addition) of anti-epileptic drugs less than 14 days prior to NeuroBlate treatment
    • Current steroid dosage of more than 16 mg dexamethasone per day or equivalent
    • Pregnant or planning to become pregnant

What is involved

  • Surgical procedure to treat your brain tumor
  • Medical history
  • Biopsy
  • MRI
  • Physical exam
  • Neuroexam
  • Karnofsky Performance Score
  • Pregnancy test
  • Blood test
  • Questionnaires

Compensation

Study subjects will be given a $25.00 gift card after completion of the study visits. Total compensation for completion of these study visits (total of 12 visits) will amount to $300.00.

Contact Information

Study Coordinator
Wendy Jenkins, RN
Email
[email protected]
Phone
336.716.3842
Principal Investigator
Roy Ervin Strowd, III, MD

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Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.