Using laser therapy and radiation to treat newly diagnosed gliomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a treatment regimen combining Laser Interstitial Thermal Therapy (LITT) with Hypofractionated Radiation Therapy for patients with newly diagnosed gliomas. LITT serves as a minimally invasive alternative to surgical resection, allowing for immediate initiation of radiation therapy while also providing a tissue diagnosis of the tumor. The study aims to assess the effectiveness and safety of this combined approach in managing high-grade gliomas.

Why it matters

Who can join: the full rules

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

Where it's running

• Maryland Proton Treatment Center
  Baltimore, Maryland, United States Recruiting
• University of Maryland Greenebaum Cancer Center
  Baltimore, Maryland, United States Recruiting
• UCH Kaufman Cancer Center
  Bel Air, Maryland, United States Recruiting
• Central Maryland Radiation Oncology
  Columbia, Maryland, United States Recruiting
• Baltimore Washington Medical Center
  Glen Burnie, Maryland, United States Recruiting

Study contacts

• Study coordinator: Mark Mishra, MD
• Email: mmishra@umm.edu
• Phone: 410-328-6080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.