GliomaUS-GLIOMANCT03531333
Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.
A study testing ultrasound guided surgery. in people with Glioma, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The main goal of high grade glioma (HGG) surgery is to achieve gross total resection (GTR) without causing new neurological deficits1-8. Intraoperative navigated high resolution ultrasound (US) is a promising new tool to acquire real-time intraoperative images to localize and to resect gliomas9-12. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- ultrasound guided surgery.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2016to 1 Aug 2020
- 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
- Individuals of 18 years or older
- Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma
- KPS ≥ 60
- Preoperative intention to perform gross-total resection of the enhancing tumor
- Written informed consent conform ICH-GCP
Who cannot join
- Tumours crossing the midline basal ganglia, cerebellum, or brain stem prohibiting gross total resection
- Multifocal contrast enhancing lesions
- Pre-existing neurological deficit (e.g. aphasia, hemiparesis) due to neurological diseases (e.g. stroke)
- Inability to give consent because of dysphasia or language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.
The main goal of high grade glioma (HGG) surgery is to achieve gross total resection (GTR) without causing new neurological deficits1-8. Intraoperative navigated high resolution ultrasound (US) is a promising new tool to acquire real-time intraoperative images to localize and to resect gliomas9-12. The aim of this study was to investigate whether intraoperative guided surgery leads to a higher rate of GTR, when compared with standard non-ultrasound guided surgery.
Read the detailed description
Study design:
The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure.
Study population:
Fifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first MRI scan.
Intervention:
The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
Main study parameters/endpoints:
- Gross total resection (yes/no)
- Extent of resection (%)
- Neurological outcome (Karnofsky Performance Status)
- Quality of Life (EORTC QLQ-C30 and QLQ-BN20 quality of life questionnaire)
- Surgery associated neurological deficits (National Institutes of Health Stroke Scale)
- Adverse events (classified according to the US National Cancer Institute common toxicity criteria version 4.0)
- Survival time (days)
- Conditions
- Glioma
- Being tested
- ultrasound guided surgery.
- Keywords
- Glioma, intraoperative ultrasound, gross total resection, quality of life
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided surgery.Procedure or surgery
during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | ultrasound navigation guided surgery. Receives: Procedure: ultrasound guided surgery. |
| Non-ultrasound | No intervention | standard surgery without ultrasound guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross total resection (Yes or No)
Gross-total resection (yes vs. no): No residual contrast enhancement on post-operative MRI scans; 100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans.
Measured: within 48 hours after surgery
Secondary outcomes (6)
Extent of resection (%)
as a continous variable The extent of resection (%) is a secondary outcome measurement defined as the residual tumor volumes on post-operative MRI studies compared to the operative tumor volume.
Measured: within 48 hours after surgery
Neurological outcome (Karnofsky Performance status)
Karnofsky Performance status
Measured: within 1 week after surgery
Quality of Life (QLQ C30 questionnaires)
QLQ C30 questionnaires
A brain tumor specific quality of life measurement tool
Measured: 1, 3 and 6 months after surgery
Quality of Life (QLQ BN20 questionnaires)
QLQ BN20 questionnaires
A brain tumor specific quality of life measurement tool
Measured: 1, 3 and 6 months after surgery
Surgery associated neurological deficits (National Institutes of Health Stroke Scale)
National Institutes of Health Stroke Scale
0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused typically by a stroke, however it is also used for tumor studies to assess functioning on the level of speech, motor and sensory functions.
Measured: 1 month after surgery
Survival (time in days)
time measured from surgery until death in days.
This study has a follow up of 6 months. However, when patients are alive at months after surgery, we will contact the general practictioner of the patient 15 months after the trial to obtain survival data.
Measured: status will be checked 15 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Nov 2016
- Primary completion31 Dec 2019
- Study completion1 Aug 2020 (estimated)
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 GliomaStudies of the same condition, open and under way.
- More trials run by Erasmus 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure. The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Coolsingel
- Responsible party
- Principal investigator, A.J.P.E. VIncent, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531333
- Sponsor's protocol ID
- MEC-2015-46
- Acronym
- US-GLIOMA
- Status last verified
- Jan 2020
- First submitted
- 2 Nov 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Incekara F, Smits M, Dirven L, Bos EM, Balvers RK, Haitsma IK, Schouten JW, Vincent AJPE. Intraoperative B-Mode Ultrasound Guided Surgery and the Extent of Glioblastoma Resection: A Randomized Controlled Trial. Front Oncol. 2021 May 19;11:649797. doi: 10.3389/fonc.2021.649797. eCollection 2021.
PubMed 34094939
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.
- ClinicalTrials.gov ID
- NCT03531333
- Acronym / sponsor ID
- US-GLIOMA / MEC-2015-46
- Conditions
- Glioma
- Keywords
- Glioma, intraoperative ultrasound, gross total resection, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Stichting Coolsingel
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 21 May 2018 (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.
The main goal of high grade glioma (HGG) surgery is to achieve gross total resection (GTR) without causing new neurological deficits1-8. Intraoperative navigated high resolution ultrasound (US) is a promising new tool to acquire real-time intraoperative images to localize and to resect gliomas9-12. The aim of this study was to investigate whether intraoperative guided surgery leads to a higher rate of GTR, when compared with standard non-ultrasound guided surgery.
Detailed description
Study design:
The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure.
Study population:
Fifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first MRI scan.
Intervention:
The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
Main study parameters/endpoints:
- Gross total resection (yes/no)
- Extent of resection (%)
- Neurological outcome (Karnofsky Performance Status)
- Quality of Life (EORTC QLQ-C30 and QLQ-BN20 quality of life questionnaire)
- Surgery associated neurological deficits (National Institutes of Health Stroke Scale)
- Adverse events (classified according to the US National Cancer Institute common toxicity criteria version 4.0)
- Survival time (days)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure. The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Procedure: ultrasound guided surgery.ultrasound navigation guided surgery. |
| Non-ultrasound | No intervention | –standard surgery without ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals of 18 years or older
- Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma
- KPS ≥ 60
- Preoperative intention to perform gross-total resection of the enhancing tumor
- Written informed consent conform ICH-GCP
Key exclusion criteria (4 listed)
- Tumours crossing the midline basal ganglia, cerebellum, or brain stem prohibiting gross total resection
- Multifocal contrast enhancing lesions
- Pre-existing neurological deficit (e.g. aphasia, hemiparesis) due to neurological diseases (e.g. stroke)
- Inability to give consent because of dysphasia or language barrier
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 |
|---|---|---|
| ultrasound guided surgery.during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection. | Procedure or surgery | Ultrasound |
Primary outcome
Gross total resection (Yes or No)
Time frame: within 48 hours after surgery
Gross-total resection (yes vs. no): No residual contrast enhancement on post-operative MRI scans; 100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans.
6 secondary outcomes
Extent of resection (%)
Time frame: within 48 hours after surgery
Neurological outcome (Karnofsky Performance status)
Time frame: within 1 week after surgery
Quality of Life (QLQ C30 questionnaires)
Time frame: 1, 3 and 6 months after surgery
Quality of Life (QLQ BN20 questionnaires)
Time frame: 1, 3 and 6 months after surgery
Surgery associated neurological deficits (National Institutes of Health Stroke Scale)
Time frame: 1 month after surgery
Survival (time in days)
Time frame: status will be checked 15 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 34094939Incekara F, Smits M, Dirven L, Bos EM, Balvers RK, Haitsma IK, Schouten JW, Vincent AJPE. Intraoperative B-Mode Ultrasound Guided Surgery and the Extent of Glioblastoma Resection: A Randomized Controlled Trial. Front Oncol. 2021 May 19;11:649797. doi: 10.3389/fonc.2021.649797. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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 ultrasound guided surgery. in people with Glioma, run by Erasmus 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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?
Results are not available in the source record.
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?
Gross total resection (Yes or No) (time frame: within 48 hours after surgery). 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 NCT03531333, 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 13 Jan 2020.