NCT04699773 LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)
| NCT ID | NCT04699773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2021-02-20 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2021-02-20 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04699773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04699773 currently recruiting?
Yes, NCT04699773 is actively recruiting participants. Contact the research team at mmishra@umm.edu for enrollment information.
Where is the NCT04699773 trial being conducted?
This trial is being conducted at Baltimore, United States, Baltimore, United States, Bel Air, United States, Columbia, United States and 1 additional location.
Who is sponsoring the NCT04699773 clinical trial?
NCT04699773 is sponsored by University of Maryland, Baltimore. The trial plans to enroll 32 participants.