LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)

  • STATUS
    Recruiting
  • End date
    Dec 15, 2025
  • participants needed
    32
  • sponsor
    University of Maryland, Baltimore
Updated on 15 May 2022
karnofsky performance status
MRI

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.

Description

Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of the tumor prior to initiating radiation therapy.

Details
Condition Glioma, Glioblastoma, Brain Tumor
Treatment hypofractionated radiation therapy, LITT
Clinical Study IdentifierNCT04699773
SponsorUniversity of Maryland, Baltimore
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with radiographic evidence of suggestive of a primary high-grade glioma
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
History and physical including neurological exam within 30 days prior to registration
Karnofsky performance status ≥50% within 30 days prior to registration
Age ≥ 18 years old
Patients must have signed an approved informed consent
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
Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration

Exclusion Criteria

Patients that are not surgical candidates for stereotactic biopsy or laser ablation
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
Infratentorial tumor or evidence of leptomeningeal spread
Inability to undergo a MRI
Pregnant or breast-feeding women
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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