Recruiting

LITT & RT

Sponsor:

University of Maryland, Baltimore

Code:

NCT04699773

Conditions

Glioma

Glioblastoma

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LITT

Hypofractionated Radiation Therapy

Study Details

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.

Conditions

Glioma

Glioblastoma

Brain Tumor

Study ID

NCT04699773

Start date

Feb 20, 2021

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LITT with Hypofractionated RT

Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 25Gy/10 fractions.

Interventions

LITT

This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.

Hypofractionated Radiation Therapy

Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.

Primary outcome measure

  • Adverse Events [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Maryland Proton Treatment Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

University of Maryland Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

UCH Kaufman Cancer Center

Recruiting

Bel Air, Maryland, United States, 21014

Contacts

Mark Mishra, MD

410-328-6080

Linda Romar

lromar@umm.edu

Central Maryland Radiation Oncology

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Mark Mishra, MD

410-328-6080

Caitlin Eggleston

caitlineggleston@umm.edu

Baltimore Washington Medical Center

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Laser Interstitial Thermal Therapy
  • Brain Tumor
  • Radiotherapy
  • Proton Therapy
  • Glioma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-05-06.