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

NCT ID: NCT01698437

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2016-05-31

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.

Conditions

Malignant Brain Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Transcranial MR-Guided Focused Ultrasound for Brain Tumors

Group Type: OTHER

Non-invasive intervention with focused ultrasound (ExAblate 4000)

Intervention Type: DEVICE

Non-invasive brain intervention using MR-guided focused ultrasound

Interventions

Non-invasive intervention with focused ultrasound (ExAblate 4000)

Non-invasive brain intervention using MR-guided focused ultrasound

Intervention Type: DEVICE

Other Intervention Names

ExAblate 4000

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier - Fandino, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Neurosurgery, Kantonsspital Aarau, 5001 Aarau, Switzerland

Ernst - Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Center for MR-Research, University Children's Hospital Zurich, Switzerland

Locations

MR-Center, University Children's Hospital

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

AG2010/026,ZH 2010-0543/3

Identifier Type: -

Identifier Source: org_study_id