Hi-SMILE: Prospective study on stereotactic minimally-invasive laser interstitial thermal therapy in patients with recurrent glioblastoma and high-grade glioma
Recruiting
- Conditions
- C71Malignant neoplasm of brain
- Registration Number
- DRKS00030073
- Lead Sponsor
- eurochirurgische KlinikSektion stereotaktische NeurochirurgieUniversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients of legal age with previously histologically confirmed glioblastoma or high-grade glioma (CNS WHO 4°) and
imaging suspicion of supratentorial recurrence
- Indication for LITT treatment with biopsy sampling if open resection is considered too risky
resection is deemed too risky or not possible by specialist neurosurgeon.
(Common factors in favor of LITT treatment:
a) tumor volume <30cm3 and/or <3cm diameter along the
longest axis of extension
b) Karnofsky Performance Index of 70% or higher).
Exclusion Criteria
- Patients not able to give consent
- MRI imaging not possible
- Expected survival <3 months
- Presence of absolute contraindications for general anesthesia and/or surgery
- Pregnant patients
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eurological and functional status as well as quality of life of patients with patients with glioblastoma and high-grade glioma recurrences and LITT therapy (collected via scores: mRS, KPS, NIHSS and validated questionnaires: HADS-D, EORT QLQ-BN20, EORT QLQ-C30).
- Secondary Outcome Measures
Name Time Method Progression-free survival & overall survival (Kaplan-Meier curves).<br><br>Rate, type and severity of complications of LITT<br><br>Comparison between planned and actual ablation volume<br><br>Comparison between planned and actual location of the laser catheter tip<br><br>Course of preoperative expected and postoperative experienced treatment burden (NRS-based).