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

Malignant Brain Tumors Clinical Trial

— FUS-Tumor  

Official title:

MR-guided Ultrasound-Neurosurgery for the Treatment of Malignant Brain Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698437
• Other study ID #: AG2010/026,ZH 2010-0543/3
• Status: Completed
• Phase: Phase 1
• First received: May 29, 2012
• Last updated: June 2, 2016
• Start date: February 2011
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Brain Neoplasms
• Malignant Brain Tumors

Intervention

Device:
• Non-invasive intervention with focused ultrasound (ExAblate 4000)
Non-invasive brain intervention using MR-guided focused ultrasound

Locations

Country	Name	City	State
Switzerland	MR-Center, University Children's Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion Size	Size of lesion in the tumor tissue for each sonication as a function of applied energy/temperature.	3 months	Yes
Primary	Patient Safety	Number of Participants with Adverse Events as a Measure of Safety and Tolerability.	3 months	Yes