Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LITT arm | Experimental | Patients will be randomized to receive biopsy and LITT (n=10) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser ablation thermal therapy | Procedure | The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival and progression free survival | To assess preliminary data on survival | 12 months |
| Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome) | To assess preliminary data on quality of life |
Not provided
Inclusion criteria
In order to be eligible to participate in the study, a patient must meet all of the following criteria:
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud UMC | Nijmegen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37505379 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 3 months |
| European Organisation for Research and Treatment of Cancer - BN20 brain module | To assess preliminary data on quality of life | 3 months |
| Tumor volume evolution | To assess tumour volume evolution on MRI at 3 months post-operatively | 3 months |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |