Clinical Trials for Brain Tumours

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Phase I Clinical Trials

The purpose of these studies is to evaluate the safety and feasibility of ExAblate Neuro using transcranial MRI guided Focused Ultrasound Surgery in the Treatment of Brain Tumors. Current undergoing trials: 



A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors
(NCT01473485 - ClinicalTrials.gov Identifier) 

 Primary Outcome Measures:

  • To evaluate the incidence and severity of Adverse Events (AEs) associated with the ExAblate Transcrainal device during ExAblate treatment


Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


Criteria

Inclusion Criteria:

  • Men or women.

  • Age between 18 and 75 years, inclusive.

  • Able and willing to give informed consent.

  • Able to tolerate pre / post - procedure steroid treatment

  • Subjects with recurrent or progressive glioma who have failed standard therapy with surgery and/or radiation for whom local therapy has been requested by the neuro-oncologist. This treatment will be offered as an option for those patients where neither surgery nor repeat radiotherapy is advised by the multidisciplinary team. OR Patients with metastatic brain cancer that has progressed despite prior radiotherapy and local therapy is requested by the oncologist. This treatment will be offered as an option for those patients where surgery is not indicated and discussed with the potential options for repeat radiotherapy or salvage radiosurgery by the multidisciplinary team.

  • The targeted tumor tissue is located in the cerebral hemispheres, > 2.5 cm from the inner table of the skull. Non-targeted parts of the tumor may extend outside the treated tumor limits.

  • Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.

·        No more than 1 Brain Met can be treated under this protocol

  • Size of the targeted portion of the tumor (i.e. prescribed ROT) is less than 2.5 cm in diameter (8 cm3 in volume). The non-targeted tumor tissue may exceed the targeted volume.

  • Karnofsky rating 70-100.

  • ASA score 1-3.

  • Able to communicate sensations during the ExAblate MRGFUS procedure.

  • Able to attend all study visits (i.e., life expectancy of at least 3 months).

  • At least 14 days passed since last brain surgery or radiation therapy

Exclusion Criteria:

  • The tumor's not visible on the pre-therapy imaging
  • The tumor presenting the following imaging characteristics

·        Brain edema and/or mass effect that causes midline shift or shift in wall of the third (3rd) ventricle of more than 10-mm.
·        Targeted area (i.e.: ROT) less than 5 millimeters from primary branches of cerebral vessels, dural sinuses, the hypophysis or cranial nerves
·        Evidence of recent (less than 2 weeks) intracranial hemorrhage.
·        Containing calcifications in the focused ultrasound sonication beam path in the event system tools cannot tailor the treatment around these calcification spots

  • The sonication pathway to the tumor involves
·        More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
·        Clips or other metallic implanted objects in the skull or the brain, except shunts.
  • The subject presents with:

·        Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
·        Unstable hemodynamic status including:
·        Documented myocardial infarction within six months of enrollment.
·        Symptomatic coronary artery stenosis.
·        Congestive heart disease not controlled by medication.
·        Cardiac pacemaker.
·        Severe hypertension (diastolic BP > 100 on medication).

  • Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.: non-steroidal anti-inflammatory drugs (NSAIDs), statins)
  • Patients with history of bleeding disorder or with history of spontaneous haemorrhage tumour
  • Abnormal level of platelets (< 100000), PT (>14) or PTT (>36), and INR > 1.3.
  • Documented cerebral infarction within past 12 months
  • TIA or stroke in the last 1 month.
  • Patients with cerebral or systemic vasculopathy:

·        Symptomatic systemic vascular disease is defined as cardiovascular disease which prevents any procedure in MRI where ECG cannot be obtained (i.e. coronary disease). These patients must be excluded

  • Insulin-dependent diabetes mellitus.
  • Patients taking immunosuppressants (corticosteroids to prevent/treat brain edema are permitted).
  • Known sensitivity to gadolinium-DTPA.


Contacts and Locations

Canada
Sunnybrook Health Science Centre, Toronto, Canada
Principal Investigators: Todd Mainprize, MD
Contact: Julie Gundry  
Phone: 416-480-6100, ext 7362    
email: julie.gundry@sunnybrook.ca



MR-guided Ultrasound-Neurosurgery for the Treatment of Malignant Brain Tumors
(NCT01698437 - ClinicalTrials.gov Identifier)

 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.

Eligibility

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


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 than 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 implantates such as durapatch, skullreconstruction 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.


Contacts and Locations

Switzerland
MR-Center, University Children's Hospital
Zurich, Switzerland, CH-8032
Contact: Ernst - Martin, MD, ​Principal Investigator    
Phone: +41 44 266 7111 ext 7437   
email: ernst.martin@kispi.uzh.ch  
Contact: Javier - Fandino, MD
Phone: +41 93 66 838 62
e.mail: javier.fandino@ksa.ch         



A Feasibility Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Lesions
(NCT00147056-ClinicalTrials.gov Identifier)

Primary Outcome Measures:
MRI Guilded Focused ultrasound feasibility study for brain tumors

Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


Criteria

Inclusion Criteria:

  • Subjects with only recurrent glioblastoma (grade IV astro) and recurrent metastatic cancer to the brain for whom surgery has not been advised by a physician that is not associated with this study.
  • Lesion(s) to be treated are located in the cerebral hemispheres, > 1.5 cm from the cortex and the dura.
  • Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans.
  • Three or less lesion(s) in the brain
  • Size of solid mass of lesions is less than 2.5 cm in diameter (8 cm3 in volume).
  • Men or women.
  • Age between 18 and 70 years, inclusive.
  • Karnofsky rating 70-100 (See Appendix A).
  • ASA score 1-2.
  • Able and willing to give informed consent.
  • Able to communicate sensations during the MRGFUS procedure.
  • Apparently able to attend all study visits (i.e., life expectancy of at least 3 months).
  • At least 14 days passed since last tumor therapy (i.e. surgery, chemotherapy, radiation therapy).
  • No additional tumor therapies anticipated for at least 30 days (i.e. surgery, chemotherapy, radiation therapy).
Exclusion Criteria:

 a) The lesion's appearance on the pre-therapy MR and CT scans:

  • Brain edema and/or mass effect that causes midline shift or shift in wall of ventricle of more than 5 mm.
  • Localized in the brain stem or the posterior fossa.
  • Less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.
  • Evidence of recent (less than 2 weeks) hemorrhage.
  • Containing calcifications. b) The sonication pathway to the lesion involves:
a. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
b. Clips or other implanted objects in the skull or the brain. c) The subject presents with:
  • Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papaedama).
  • Unstable hemodynamic status including:

i. Documented myocardial infarction within six months of enrollment. ii. Symptomatic coronary artery stenosis. iii. Congestive heart disease requiring medication. iv. Anti-arrhythmic drug medication. v. Cardiac pacemaker. vi. Severe hypertension (diastolic BP > 100 on medication). c. Anti-coagulation therapy or known bleeding disorder. d. Abnormal level of platelets (< 100), PT (>14) or PTT (>36). e. Documented cerebral infarction within past 12 months. f. TIA due to arteriosclerosis in the last 1 month. g. Other known cerebral or general vasculopathy. h. Insulin-dependent diabetes mellitus. i. Immunosuppression (corticosteroids to prevent brain edema are permitted). j. Known sensitivity to gadolinium-DTPA. k. Contraindications to MRI such as non-MRI-compatible implanted devices. l. Large subjects not fitting comfortably into the MRI scanner (generally >250 lbs.) m. Difficulty to lay supine and still for up to 4 hours in the MRI unit or claustrophobia.
n. Sleep apnea. o. Positive pregnancy test (for pre-menopausal women). p. Known life-threatening systemic disease.
 
Contacts and Locations

USA
University of Virginia
Principal Investigator: Jason Sheehan MD
Contact: Jenny De Jong – study coordinator
Phone: 434-243-9986
email: jad5yc@virginia.edu

Swedish Medical Center
Seattle, Washington, United States, 98122
Principal Investigator: Charles Cobbs, MD
Contact: Colleen Ottinger
Phone: 206-320-3070
email: Focusedultrasound@swedish.org   
Contact: Mary Lessig   
Phone: 206-320-3070
email: Focusedultrasound@swedish.org   



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Clinical Trials for Brain Tumours