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LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)
RECRUITINGN/ASponsored by University of Maryland, Baltimore
Actively Recruiting
PhaseN/A
SponsorUniversity of Maryland, Baltimore
Started2021-02-20
Est. completion2027-02
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations5 sites
View on ClinicalTrials.gov →
NCT04699773
Summary
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions4
Brain TumorCancerGlioblastomaGlioma
Locations5 sites
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
UCH Kaufman Cancer Center
Bel Air, Maryland, 21014
Mark Mishra, MD410-328-6080
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
Mark Mishra, MD410-328-6080
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhaseN/A
SponsorUniversity of Maryland, Baltimore
Started2021-02-20
Est. completion2027-02
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations5 sites
View on ClinicalTrials.gov →
NCT04699773