Using laser therapy and radiation to treat newly diagnosed gliomas
Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade Gliomas
This study is testing a new treatment that combines laser therapy and radiation to see if it helps people with newly diagnosed brain tumors called gliomas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | Radiation |
| Locations | 5 sites (Baltimore, Maryland and 4 other locations) |
| Trial ID | NCT04699773 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with radiographic evidence of high-grade gliomas who are deemed suitable for LITT.
Not a fit: Patients who are not surgical candidates for stereotactic biopsy or laser ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with newly diagnosed gliomas by providing a less invasive option that allows for timely radiation therapy.
How similar studies have performed: Other studies have shown promise in using LITT for brain tumors, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.