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Met-SMILE: Prospective study on stereotactic minimally-invasive laser interstitial thermal therapy in patients breast cancer cerebral metastases

Met-SMILE: Prospective study on stereotactic minimally-invasive laser interstitial thermal therapy in patients breast cancer cerebral metastases - Met-SMILE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035192
Enrollment
30
Registered
2024-10-01
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

C79.3

Interventions

Group 1: LITT for rbreast cancer metastases: As study-specific measures, prospective collection of scores and questionnaires will occur: Functional Status: - modified Rankin Score (mRS) - Karnofsky P

Sponsors

Neurochirurgische Klinik, Sektion stereotaktische Neurochirurgie
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Patients of legal age with previously histologically confirmed breast cancer and imaging suspicious of 1-4 symptomatic brain metastases -Indication for LITT treatment with biopsy sampling if open resection is considered too riskyresection is deemed too risky or not possible by specialist neurosurgeon. Common factors in favor of LITT treatment: - tumor volume <30cm3 and/or <2.5cm diameter along the shortes axis of extension - Karnofsky Performance Index of 70% or higher) - supratentorial location of the targeted metastasis

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 patient

Design outcomes

Primary

MeasureTime frame
Neurological and functional status as well as quality of life of patients with patients with breast cancer brain metastases and LITT therapy (collected via scores: mRS, KPS, NIHSS and validated questionnaires: HADS-D, EORT QLQ-BN20, EORT QLQ-C30).

Secondary

MeasureTime 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, Sektiomn stereotaktische Neurochirurgie

neurochirurgie.nch@med.uni-heidelberg.de+4962216307

Outcome results

None listed

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