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LITT Palliative Treatment for Patients With Malignant Gliomas

NCT03176160 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-02-27

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Palliative regimen consisting of LITT

Minimally invasive technique to necrotize intracranial lesions

Sponsors & Collaborators

Principal Investigators

  • Peter S Fecci, MD, PhD · Duke University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2020-06-30
Completion
2022-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176160 on ClinicalTrials.gov