Malignant Brain TumorsPhase 1FUS-TumorNCT01698437
Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Brain Tumors
A Phase 1 study testing Non-invasive intervention with focused ultrasound (ExAblate 4000) in people with Malignant Brain Tumors, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
Focused Ultrasound Focused ultrasound is an attractive method for non-invasive thermal ablation of soft tissue tumors. Treatment begins by acquiring a series of MR images of the target organ. The physician then identifies a target volume in the MR images and delineates the treatment contours on the images. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Brain Tumors
- What is being tested?
- Non-invasive intervention with focused ultrasound (ExAblate 4000)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2011to May 2016
- Phase
- Phase 1
- 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
- Male or female ages over 18 years old that give informed written consent to participate in study. Females in reproductive age have to provide a negative serum pregnancy test.
- Patients with primary diagnosis (biopsy proven) of a malignant glioma or a recurrent glioma, that do not accept a conventional tumor resection or where a conventional tumor resection is not indicated according to both the neurosurgeon in charge and the neuro-oncology colloquium at the Kantonsspital Aarau.
- Or:
- Patients with a supratentorial brain metastasis of a malignant tumor, that do not accept a conventional tumor resection or where a conventional tumor resection is not indicated according to the neurosurgeon in charge and the neuro-oncology colloquium at the Kantonsspital Aarau.
- The portion of the tumor to be treated during one intervention is less than 3.0 cm in diameter, corresponding to a volume of ca. 14 cc.
- If the total size of the tumor is larger than 3.0 cm in diameter then eventual complementing ablations will not be performed before 2 week after the first treatment.
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- The tumor to be treated is clearly defined and can be well distinguished from surrounding brain tissue.
- The border of the targeted tumor volume has in all directions a distance of at least 2.5 cm from the inner table of the skull. Portions of the tumor that are not planned to be treated due to this safety margin will be marked.
- Patients must have an ASA score 1-2, and a Karnofsky score 70-100
Who cannot join
- All tumor Types
- Clinical or neuroradiological signs of increased intracranial pressure.
- Significantly increased vascularization of tumor in preoperative MR-angiogram or in digital subtraction angiography (DSA).
- Tumor mass effect that causes midline shift or a shift of the third (3rd) ventricle of more than 5 mm, even after steroid therapy.
- The border of the tumor portion to be treated is less then 5mm away from a main branch of a brain vessel, the venous sinuses, the pituitary gland or the cranial nerves.
- The tumor is in immediate proximity to a cystic formation.
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- Recent (less than 2 weeks) intracranial hemorrhage.
- Increased risk of bleeding: platelets < 100,000/mm3, INR > 1.3 or other coagulation disorders.
- Tumors with presumably high risk of bleeding
- Oral anticoagulant or thrombocyte aggregation suppression (e.g. ASS) that was not stopped at least 5 days before the intervention.
- Contraindication for MR-exams, such as non-MR-compatible implants or cardiac pacemaker.
- Clips and other implants in the sonication path or in the target area.
- Operation implants such as dura patch, skull reconstruction with polymethylmethacrylate (PalacosTM), titan in the sonication path.
- Infratentorial (i.e. cerebellar-) tumors.
- Contraindications for MR-contrast agents or for steroid therapy
- Allergy against local anesthesia.
- Uncontrolled arterial hypertension.
- Other life threatening diseases.
- Severe uncontrolled systemic infection.
- Hypersensitivity to contrast agents used in this study.
- Severely impaired renal function (estimated glomerular filtration rate < 30 mL/min/1.73 m2) or under dialysis.
- Inability to give informed written consent.
- Alcohol or drug abuse.
- Patients who are unreliable and will not appear for the follow up exams.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
MR-Center, University Children's Hospital
Zurich, Canton of Zurich
About this study
Official title: MR-guided Ultrasound-Neurosurgery for the Treatment of Malignant Brain Tumors
Focused Ultrasound Focused ultrasound is an attractive method for non-invasive thermal ablation of soft tissue tumors. Treatment begins by acquiring a series of MR images of the target organ. The physician then identifies a target volume in the MR images and delineates the treatment contours on the images. Therapy planning software calculates the parameters required to effectively treat the defined target volume. During the treatment an ultrasound transducer generates and focuses ultrasound energy to a focal point, called a sonication. The sonication raises the tissue temperature within a well-defined region to a degree, which causes thermal coagulation. MR images acquired during sonication provide a quantitative, real-time temperature map of the target area to confirm the location of the sonication and the size of the coagulated region. The sonication process is repeated at multiple adjacent points to cover the entire prescribed treatment volume.
- Conditions
- Malignant Brain Tumors
- Being tested
- Non-invasive intervention with focused ultrasound (ExAblate 4000)
- Keywords
- FUS, focused ultrasound, functional brain disorders, neuropathic pain, movement disorders, malignant of brain tumors
- Medical subject headings
- Neuralgia, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive intervention with focused ultrasound (ExAblate 4000)Device
Also called ExAblate 4000
Non-invasive brain intervention using MR-guided focused ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Transcranial MR-Guided Focused Ultrasound for Brain Tumors | Other | Not described Receives: Device: Non-invasive intervention with focused ultrasound (ExAblate 4000) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Size
Size of lesion in the tumor tissue for each sonication as a function of applied energy/temperature.
Measured: 3 months
Patient Safety
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
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 posted3 Oct 2012 (estimated)
- Study startFeb 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain TumorsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier - Fandino, MD, Principal investigator, Dept. of Neurosurgery, Kantonsspital Aarau, 5001 Aarau, SwitzerlandErnst - Martin, MD, Principal investigator, Center for MR-Research, University Children's Hospital Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698437
- Sponsor's protocol ID
- AG2010/026,ZH 2010-0543/3
- Acronym
- FUS-Tumor
- Status last verified
- Jun 2016
- First submitted
- 29 May 2012
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-guided Ultrasound-Neurosurgery for the Treatment of Malignant Brain Tumors
- ClinicalTrials.gov ID
- NCT01698437
- Acronym / sponsor ID
- FUS-Tumor / AG2010/026,ZH 2010-0543/3
- Conditions
- Malignant Brain Tumors
- Keywords
- FUS, focused ultrasound, functional brain disorders, neuropathic pain, movement disorders, malignant of brain tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Oct 2012 (estimated)
- 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.
Focused Ultrasound Focused ultrasound is an attractive method for non-invasive thermal ablation of soft tissue tumors. Treatment begins by acquiring a series of MR images of the target organ. The physician then identifies a target volume in the MR images and delineates the treatment contours on the images. Therapy planning software calculates the parameters required to effectively treat the defined target volume. During the treatment an ultrasound transducer generates and focuses ultrasound energy to a focal point, called a sonication. The sonication raises the tissue temperature within a well-defined region to a degree, which causes thermal coagulation. MR images acquired during sonication provide a quantitative, real-time temperature map of the target area to confirm the location of the sonication and the size of the coagulated region. The sonication process is repeated at multiple adjacent points to cover the entire prescribed treatment volume.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial MR-Guided Focused Ultrasound for Brain Tumors | Other | Device: Non-invasive intervention with focused ultrasound (ExAblate 4000) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ages over 18 years old that give informed written consent to participate in study. Females in reproductive age have to provide a negative serum pregnancy test.
- Patients with primary diagnosis (biopsy proven) of a malignant glioma or a recurrent glioma, that do not accept a conventional tumor resection or where a conventional tumor resection is not indicated according to both the neurosurgeon in charge and the neuro-oncology colloquium at the Kantonsspital Aarau.
- Patients with a supratentorial brain metastasis of a malignant tumor, that do not accept a conventional tumor resection or where a conventional tumor resection is not indicated according to the neurosurgeon in charge and the neuro-oncology colloquium at the Kantonsspital Aarau.
- The portion of the tumor to be treated during one intervention is less than 3.0 cm in diameter, corresponding to a volume of ca. 14 cc.
- If the total size of the tumor is larger than 3.0 cm in diameter then eventual complementing ablations will not be performed before 2 week after the first treatment.
Key exclusion criteria (24 listed)
- All tumor Types
- Clinical or neuroradiological signs of increased intracranial pressure.
- Significantly increased vascularization of tumor in preoperative MR-angiogram or in digital subtraction angiography (DSA).
- Tumor mass effect that causes midline shift or a shift of the third (3rd) ventricle of more than 5 mm, even after steroid therapy.
- The border of the tumor portion to be treated is less then 5mm away from a main branch of a brain vessel, the venous sinuses, the pituitary gland or the cranial nerves.
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 |
|---|---|---|
| Non-invasive intervention with focused ultrasound (ExAblate 4000)Also: ExAblate 4000Non-invasive brain intervention using MR-guided focused ultrasound | Device | Transcranial MR-Guided Focused Ultrasound for Brain Tumors |
Primary outcome
Lesion Size
Time frame: 3 months
Size of lesion in the tumor tissue for each sonication as a function of applied energy/temperature.
Patient Safety
Time frame: 3 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
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 3 Jun 2016.
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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.
Javier - Fandino, MD principal investigator
Dept. of Neurosurgery, Kantonsspital Aarau, 5001 Aarau, Switzerland
Ernst - Martin, MD principal investigator
Center for MR-Research, University Children's Hospital Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Non-invasive intervention with focused ultrasound (ExAblate 4000) in people with Malignant Brain Tumors, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 9 inclusion and 24 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 3 Jun 2016. 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 Switzerland. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lesion Size (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2016.