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Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Brain Tumors (FUS-Tumor)

Primary Purpose

Malignant Brain Tumors

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Non-invasive intervention with focused ultrasound (ExAblate 4000)
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Malignant Brain Tumors focused on measuring FUS, focused ultrasound, functional brain disorders, neuropathic pain, movement disorders, malignant of brain tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. 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.

  3. 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.

  4. The tumor to be treated is clearly defined and can be well distinguished from surrounding brain tissue.
  5. 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.
  6. Patients must have an ASA score 1-2, and a Karnofsky score 70-100

Exclusion Criteria:

All tumor Types

  1. Clinical or neuroradiological signs of increased intracranial pressure.
  2. Significantly increased vascularization of tumor in preoperative MR-angiogram or in digital subtraction angiography (DSA).
  3. Tumor mass effect that causes midline shift or a shift of the third (3rd) ventricle of more than 5 mm, even after steroid therapy.
  4. 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.
  5. The tumor is in immediate proximity to a cystic formation.
  6. Recent (less than 2 weeks) intracranial hemorrhage.
  7. Increased risk of bleeding: platelets < 100,000/mm3, INR > 1.3 or other coagulation disorders.
  8. Tumors with presumably high risk of bleeding
  9. Oral anticoagulant or thrombocyte aggregation suppression (e.g. ASS) that was not stopped at least 5 days before the intervention.
  10. Contraindication for MR-exams, such as non-MR-compatible implants or cardiac pacemaker.
  11. Clips and other implants in the sonication path or in the target area.
  12. Operation implants such as dura patch, skull reconstruction with polymethylmethacrylate (PalacosTM), titan in the sonication path.
  13. Infratentorial (i.e. cerebellar-) tumors.
  14. Contraindications for MR-contrast agents or for steroid therapy
  15. Allergy against local anesthesia.
  16. Uncontrolled arterial hypertension.
  17. Other life threatening diseases.
  18. Severe uncontrolled systemic infection.
  19. Hypersensitivity to contrast agents used in this study.
  20. Severely impaired renal function (estimated glomerular filtration rate < 30 mL/min/1.73 m2) or under dialysis.
  21. Inability to give informed written consent.
  22. Alcohol or drug abuse.
  23. Patients who are unreliable and will not appear for the follow up exams.

Sites / Locations

  • MR-Center, University Children's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Transcranial MR-Guided Focused Ultrasound for Brain Tumors

Arm Description

Outcomes

Primary Outcome Measures

Lesion Size
Size of lesion in the tumor tissue for each sonication as a function of applied energy/temperature.
Patient Safety
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Secondary Outcome Measures

Full Information

First Posted
May 29, 2012
Last Updated
June 2, 2016
Sponsor
University Children's Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01698437
Brief Title
Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Brain Tumors
Acronym
FUS-Tumor
Official Title
MR-guided Ultrasound-Neurosurgery for the Treatment of Malignant Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Brain Tumors
Keywords
FUS, focused ultrasound, functional brain disorders, neuropathic pain, movement disorders, malignant of brain tumors

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial MR-Guided Focused Ultrasound for Brain Tumors
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Non-invasive intervention with focused ultrasound (ExAblate 4000)
Other Intervention Name(s)
ExAblate 4000
Intervention Description
Non-invasive brain intervention using MR-guided focused ultrasound
Primary Outcome Measure Information:
Title
Lesion Size
Description
Size of lesion in the tumor tissue for each sonication as a function of applied energy/temperature.
Time Frame
3 months
Title
Patient Safety
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier - Fandino, MD
Organizational Affiliation
Dept. of Neurosurgery, Kantonsspital Aarau, 5001 Aarau, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernst - Martin, MD
Organizational Affiliation
Center for MR-Research, University Children's Hospital Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
MR-Center, University Children's Hospital
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

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Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Brain Tumors

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