MR-guided LITT therapy in patients with primary irresectable glioblastoma: a randomized pilot study

MR-guided LITT therapy in patients with primary irresectable glioblastoma: a randomized pilot study - EMITT-pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55122

Enrollment

Registered

2020-09-22

Start date

2021-01-22

Completion date

Unknown

Last updated

2024-10-15

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

Conditions

brain cancer glioblastoma

Interventions

Patients will be randomized to receive either (i) biopsy and LITT (n=10) or (ii) biopsy only (n=10).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Informed consent, age >18-year-old - Supratentorial localization - Maximal volume = 70

Exclusion criteria

Exclusion criteria: - Contra-indication for general anaesthesia or MRI - Lesion >70cc on post-contrast MRI on the day before intervention. - Non-glioblastoma diagnosis as per frozen section analysis - Pregnancy

Design outcomes

Primary

Measure	Time frame
The main goal of the study is to assess technical feasibility and safety of LITT at our center and to assess practical feasibility of a future multicentre randomized controlled trial with the same design. Safety and technical feasibility will be assessed by an expert committee, consisting of head of department, independent expert and project leader. To assess safety, the following endpoints will be considered: - 30-days mortality - Complications Clavien Dindo >/= 3 The procedure will be deemed feasible when: - Time from inclusion to procedure	—

Measure

Time frame

The main goal of the study is to assess technical feasibility and safety of LITT at our center and to assess practical feasibility of a future multicentre randomized controlled trial with the same design. Safety and technical feasibility will be assessed by an expert committee, consisting of head of department, independent expert and project leader. To assess safety, the following endpoints will be considered: - 30-days mortality - Complications Clavien Dindo >/= 3 The procedure will be deemed feasible when: - Time from inclusion to procedure

—

Secondary

Measure	Time frame
Secondary endpoints of the study are: - Overall and progression-free survival (OS, PFS) at 3 months after treatment and change in quality of life (QoL) before and 3 months after treatment will be recorded and used to implement power analysis of a future randomized trial. No comparative statistical analysis will be performed in this pilot study on OS, PFS and QoL given the small amount of patients included. - Tumour volume evolution on pre-operative, post-procedure and 3 months post-operative MRI. - Learning curve (measured as evolution of duration of the intervention, ablation percentage and complications).	—

Measure

Time frame

Secondary endpoints of the study are: - Overall and progression-free survival (OS, PFS) at 3 months after treatment and change in quality of life (QoL) before and 3 months after treatment will be recorded and used to implement power analysis of a future randomized trial. No comparative statistical analysis will be performed in this pilot study on OS, PFS and QoL given the small amount of patients included. - Tumour volume evolution on pre-operative, post-procedure and 3 months post-operative MRI. - Learning curve (measured as evolution of duration of the intervention, ablation percentage and complications).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)