Hi-SMILE: Prospective study on stereotactic minimally-invasive laser interstitial thermal therapy in patients with recurrent glioblastoma and high-grade glioma

Hi-SMILE: Prospective study on stereotactic minimally-invasive laser interstitial thermal therapy in patients with recurrent glioblastoma and high-grade glioma - Hi-SMILE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030073

Enrollment

Registered

2022-08-25

Start date

2023-02-27

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C71

Interventions

Group 1: LITT for recurrent glioblastoma and other hogh-grade gliomas: As study-specific measures, prospective collection of scores and questionnaires will occur: Functional Status: - modified Rankin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Neurological 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

Measure	Time frame
Progression-free survival & overall survival (Kaplan-Meier curves). Rate, type and severity of complications of LITT Comparison between planned and actual ablation volume Comparison between planned and actual location of the laser catheter tip Course of preoperative expected and postoperative experienced treatment burden (NRS-based).	—

Countries

Germany

Contacts

Public ContactMartin Jakobs

Neurochirurgische Klinik Universitätsklinikum Heidelberg

neurochirurgie.nch@med.uni-heidelberg.de+496221566307

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026