GlioblastomaEMITTNCT04596930
MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma
A study testing Laser ablation thermal therapy in people with Glioblastoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Laser ablation thermal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jan 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Randomized Pilot Study
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),
Read more
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
- Being tested
- Laser ablation thermal therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser ablation thermal therapyProcedure or surgery
The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance
| Study group | Role | What they receive |
|---|---|---|
| LITT arm | Experimental | Patients will be randomized to receive biopsy and LITT (n=10) Receives: Procedure: Laser ablation thermal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 months
30-days mortality
To assess safety of LITT at our center in patients with irresectable glioblastoma
Measured: 30 days
Number of patients with complications
To assess safety of LITT at our center in patients with irresectable glioblastoma
Measured: 3 months
Time from inclusion to procedure
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Measured: 3 months
Time from LITT to adjuvant therapy
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Measured: 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
Measured: 3 months
Secondary outcomes (4)
Overall survival and progression free survival
To assess preliminary data on survival
Measured: 12 months
Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome)
To assess preliminary data on quality of life
Measured: 3 months
European Organisation for Research and Treatment of Cancer - BN20 brain module
To assess preliminary data on quality of life
Measured: 3 months
Tumor volume evolution
To assess tumour volume evolution on MRI at 3 months post-operatively
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start22 Jan 2021
- Primary completion11 Feb 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596930
- Sponsor's protocol ID
- NL73896.091.20
- Acronym
- EMITT
- Status last verified
- Sep 2021
- First submitted
- 15 Oct 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37505379
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04596930
- Acronym / sponsor ID
- EMITT / NL73896.091.20
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LITT arm | Experimental | Procedure: Laser ablation thermal therapyPatients will be randomized to receive biopsy and LITT (n=10) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 .
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser ablation thermal therapyThe Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance | Procedure or surgery | LITT arm |
Primary outcome
Inclusion rate of patients meeting the inclusion criteria
Time frame: 12 months
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Number drop out (informed consent)
Time frame: 30 days
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Number of patients with completed follow-up at 3 months
Time frame: 3 months
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
30-days mortality
Time frame: 30 days
To assess safety of LITT at our center in patients with irresectable glioblastoma
Number of patients with complications
Time frame: 3 months
To assess safety of LITT at our center in patients with irresectable glioblastoma
Time from inclusion to procedure
Time frame: 3 months
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Time from LITT to adjuvant therapy
Time frame: 3 months
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Ablation of 90 percent of the target lesion in at least 70 percent of patients
Time frame: 3 months
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
4 secondary outcomes
Overall survival and progression free survival
Time frame: 12 months
Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome)
Time frame: 3 months
European Organisation for Research and Treatment of Cancer - BN20 brain module
Time frame: 3 months
Tumor volume evolution
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 37505379Viozzi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser ablation thermal therapy in people with Glioblastoma, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inclusion rate of patients meeting the inclusion criteria (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.