MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma

NCT04596930 | Completed DMC

• 1 other identifier: NL73896.091.20
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: In preparation of a randomized controlled trial, the investigators aim to assess pilot data on technical feasibility and safety of laser interstitial thermal therapy (LITT) at Radboud University Medical centre and to assess practical feasibility of a randomized study in patients with primary irresectable glioblastoma, as compared with standard of care. Study design: Prospective randomized pilot study. Randomization stopped (amendment September 2nd, 2021), Study population: 20 patients aged \>= 18 with radiologically suspected diagnosis of primary glioblastoma and contra-indication for surgical resection. Intervention: Patients will be randomized to receive either (i) biopsy and LITT (n=10) or (ii) biopsy alone (n=10).

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (8)

• Inclusion rate of patients meeting the inclusion criteria

  To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial

  12 months

• Number drop out (informed consent)

  To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial

  30 days

• Number of patients with completed follow-up at 3 months

  To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial

  3 months

• 30-days mortality

  To assess safety of LITT at our center in patients with irresectable glioblastoma

  30 days

• Number of patients with complications

  To assess safety of LITT at our center in patients with irresectable glioblastoma

  3 months

• Time from inclusion to procedure

  To assess feasibility of LITT at our center in patients with irresectable glioblastoma

  3 months

• Time from LITT to adjuvant therapy

  To assess feasibility of LITT at our center in patients with irresectable glioblastoma

  3 months

• Ablation of 90 percent of the target lesion in at least 70 percent of patients

  To assess feasibility of LITT at our center in patients with irresectable glioblastoma

  3 months

Secondary Outcomes (4)

• Overall survival and progression free survival

  12 months

• Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome)

  3 months

• European Organisation for Research and Treatment of Cancer - BN20 brain module

  3 months

• Tumor volume evolution

  3 months

Study Arms (1)

LITT arm

EXPERIMENTAL

Patients will be randomized to receive biopsy and LITT (n=10)

Procedure: Laser ablation thermal therapy

Interventions

Laser ablation thermal therapy PROCEDURE

The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance

LITT arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in the study, a patient must meet all of the following criteria:
• Informed consent, age \>18-year-old
• Supratentorial localization
• Maximal volume \<=70cc on post-contrast T1 MRI
• Safe trajectory/trajectories possible for ablation of 70% of the tumour, avoiding eloquent structures or transgression of a ventricle or vessel .
• Karnofsky Performance Status (KPS) \>= 70

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud UMC

Nijmegen, Netherlands

Location

Related Publications (1)

• Viozzi I, Overduin CG, Rijpma A, Rovers MM, Laan MT. MR-guided LITT therapy in patients with primary irresectable glioblastoma: a prospective, controlled pilot study. J Neurooncol. 2023 Sep;164(2):405-412. doi: 10.1007/s11060-023-04371-x. Epub 2023 Jul 28.

  PMID: 37505379 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: January 22, 2021
• Primary Completion: February 11, 2022
• Study Completion: May 31, 2022
• Last Updated: August 9, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)