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

This study is currently recruiting participants.
Verified July 2012 by University Children's Hospital, Zurich
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01698437
First received: May 29, 2012
Last updated: September 28, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Malignant Brain Tumors
 Device: Non-invasive intervention with focused ultrasound (ExAblate 4000)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: MR-guided Ultrasound-Neurosurgery for the Treatment of Malignant Brain Tumors

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources

Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • Lesion Size [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Size of lesion in the tumor tissue for each sonication as a function of applied energy/temperature.

  • Patient Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability.


Estimated Enrollment: 10
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Transcranial MR-Guided Focused Ultrasound for Brain Tumors Device: Non-invasive intervention with focused ultrasound (ExAblate 4000)
Non-invasive brain intervention using MR-guided focused ultrasound
Other Name: ExAblate 4000

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 implantates such as durapatch, skullreconstruction 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698437

Contacts
Contact: Javier - Fandino, MD +41 62 838 66 93 javier.fandino@ksa.ch
Contact: Ernst - Martin, MD +41 44 266 71 11 ernst.martin@kispi.uzh.ch

Locations
Switzerland
MR-Center, University Children's Hospital Recruiting
Zurich, Switzerland
Contact: Ernst - Martin, MD     +41 44 266 71 11     ernst.martin@kispi.uzh.ch    
Principal Investigator: Ernst - Martin, MD            
Sub-Investigator: Beat - Werner, MSc            
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Javier - Fandino, MD Dept. of Neurosurgery, Kantonsspital Aarau, 5001 Aarau, Switzerland
Principal Investigator: Ernst - Martin, MD Center for MR-Research, University Children's Hospital Zurich, Switzerland
  More Information

No publications provided

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01698437     History of Changes
Other Study ID Numbers: AG2010/026,ZH 2010-0543/3
Study First Received: May 29, 2012
Last Updated: September 28, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Children's Hospital, Zurich:
FUS
focused ultrasound
functional brain disorders
 neuropathic pain
movement disorders
malignant of brain tumors

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013