NCT04699773

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

Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade Gliomas

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Glioma
• Glioblastoma
• Brain Tumor

Interventions

Type	Name	Description
PROCEDURE	LITT	This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
RADIATION	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.

Timeline

• Start date: 2021-02-20
• Primary completion: 2027-02-01
• Completion: 2027-12-01
• First posted: 2021-01-07
• Last updated: 2025-03-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study