Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-07 @ 11:00 PM
Study NCT ID:
NCT03176160
Status:
WITHDRAWN
Last Update Posted:
2019-02-27
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LITT Palliative Treatment for Patients With Malignant Gliomas
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Laser Interstitial Thermal Therapy (LITT) as Palliative Treatment for Patients With Malignant Glioma Requiring Standard Treatment Alternatives
Status:
WITHDRAWN
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to enroll
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to to describe the effect of a palliative regimen consisting of Laser Interstitial Thermal Therapy (LITT) on distress, quality of life (QOL), neurocognition, days in the hospital, patient disposition, and readmission in newly diagnosed World Health Organization (WHO) grade IV malignant glioma (glioblastoma (GBM) or gliosarcoma) patients unable to undergo broader surgical resection. The primary objective is to assess changes in the National Comprehensive Cancer Network (NCCN) distress thermometer in newly diagnosed WHO grade IV malignant glioma patients who receive LITT.
\*Please note: This study was originally designed as a interventional device study studying the effect of the LITT procedure; however, it was re-designed as an observational study in which the patient population being studied is approved to receive the LITT procedure.
\*Please note: This study was originally designed as a interventional device study studying the effect of the LITT procedure; however, it was re-designed as an observational study in which the patient population being studied is approved to receive the LITT procedure.
Detailed Description:
Patients will be identified from those previously approved for the LITT procedure. Following consent, 20 patients will complete NCCN distress, Quality of Life (QOL) and neuro-cognitive baseline testing, followed by the LITT procedure using the NeuroBlate® System (NBS) and intra-operative magnetic resonance imaging (MRI). Per standard clinical practice, after completing LITT, patients will undergo radiation at the discretion of the treating radiation oncologist. Patients will likewise receive concomitant and adjuvant chemotherapy (typically temozolomide) at the discretion of the treating neuro-oncologist. All patients will complete NCCN distress, QOL and neurocognitive testing immediately after the LITT procedure on post-operative day 1 as able, or immediately prior to discharge if more appropriate. Additionally, they will complete these same tests approximately 1, 3, 6, 12, and 24 months after the completion of LITT therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: