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New treatment option for Glioma
Official title LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)
ClinicalTrials.gov ID: NCT04699773
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Infratentorial tumor or evidence of leptomeningeal spread
- Inability to undergo a MRI
See the full eligibility 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.
- 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...
- Infratentorial tumor or evidence of leptomeningeal spread
- Inability to undergo a MRI
- Pregnant or breast-feeding women
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Bel Air, Maryland, United States
- Columbia, Maryland, United States
- Glen Burnie, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Bel Air, Maryland, United States; Columbia, Maryland, United States; Glen Burnie, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.