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Phase II Study to Evaluate the Safety and Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System

Phase 2
18 Years
Open (Enrolling)
Bone Cancer, Bone Metastases, Pain

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Trial Information

Phase II Study to Evaluate the Safety and Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System

Bone is the third most common organ involved by metastatic disease behind lung and liver
[6]. In breast cancer, bone is the second most common site of metastatic spread, and 90% of
patients dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize
to bone most frequently, which reflects the high incidence of both these tumors, as well as
their prolonged clinical courses. Post-cancer survival has increased with improvement in
early detection and treatments. As a consequence, the number of patients developing
metastatic bone disease during their lifetime has also increased.

Current treatments for patients with bone metastases are primarily palliative and include
localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal
therapy, radiopharmaceutical, and bisphosphonates although the primary goal of the use of
these therapies are often to address the disease itself), and analgesics (opioids and
non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as
a treatment option for bone metastases [8]. Currently, an off label use of Cryoablation
techniques are being tested as another alternative for bone Mets palliation. The main goals
of these treatments are improvement of quality of life and functional level. These goals can
be further described:

1. Pain relief

2. Preservation and restoration of function

3. Local tumor control

4. Skeletal stabilization

Treatment with external beam radiation therapy (EBRT) is the standard of care for patients
with localized bone pain, and results in the palliation of pain for many of these patients.
Twenty to 30% of patients treated with radiation therapy do not experience pain relief
[9-13]. Re-treatment rates are generally reported in the range of 10-25%. Many patients with
relapsed pain or poor response to initial radiation may be lost to follow up or may not be
referred back to oncologists for consideration of re-radiation. In addition to relapse and
re-treatment, there is an increased risk of pathologic fracture in the peri-radiation
period. The fracture rate reported in radiation studies is generally in the range of 1% to
8%. The hyperemic response weakens the adjacent bone and increases the risk of spontaneous
fracture. Furthermore, patients who have recurrent pain at a site previously irradiated may
not be eligible for further radiation therapy secondary to limitations in normal tissue
tolerance. Hesitation on the part of physicians to use a larger dose may be related to
increased long-term toxicity. Larger radiation dose produces a greater risk of complications
such as fibrosis of normal soft tissue, which can cause a decrement in the quality of life
in cases of life expectancy longer than 6 months. There may also be a greater incidence of
acute side effects of nausea and vomiting if the treatment field includes the stomach. The
percent of patients experiencing vomiting following EBRT ranges from about 5% to 30%.

A palliative treatment for painful bone metastases that is non-invasive, without long-term
toxicity and having minimal complications would be a useful tool for treating physicians and
also a beneficial option for patients suffering from painful bone metastases. Results of
preliminary studies indicate that ExAblate treatment of painful bone metastases may be a
beneficial treatment option [14, 15]. The ExAblate system is a non-invasive thermal ablation
device used in the coagulation of various types of soft tissue. The ExAblate system has the
potential to achieve the first three of the four previously mentioned goals in the treatment
of bone tumors; namely pain relief, preservation and restoration of functional levels and
local tumor control [11]. The ExAblate system used in the present study is a technological
advance over the ExAblate 2000 fixed transducer system in terms of flexibility of use and
reduction of positioning related pain to the patients. The ExAblate system used in this
study conforms to the patient's body shape at the location of the bone mets location

Inclusion Criteria:

1. Men and women age 18 and older

2. Patients who are able and willing to give consent and able to attend all study visits

3. Patients who are suffering from symptoms of bone metastases

4. Targeted tumor(s) are ExAblate device accessible and are located in ribs, extremities
(excluding joints), pelvis, shoulders and in the posterior aspects of the following
spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5)

5. Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors irrespective of

6. Patient who's targeted tumors are on bone and bone-lesion interface is more than 1cm
from the skin, major nerve or hollow viscera.

7. Targeted tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device

8. Able to communicate sensations during the ExAblate MRgFUS treatment

Exclusion Criteria:

1. Patients who either:

- Need surgical stabilization of the affected weight bearing bony structure OR

- Targeted tumor is at an impending fracture site of the weigh bearing bone. OR

- Patients with surgical stabilization of tumor site with metallic hardware

2. Target tumors-bone interface is less then 1cm from nerve bundles, bowels, skin or

3. Targeted (most painful) tumors:

- NOT visible by non-contrast MRI, OR

- NOT accessible to ExAblate device

4. Targeted tumor is in the skull

5. Patients on dialysis

6. Patients with life expectancy < 6-Months

7. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected
to hinder them from completing this study.

8. Subjects with Patients with unstable cardiac status including:

- Unstable angina pectoris on medication

- Patients with documented myocardial infarction less than 40 days prior to
protocol enrolment

- Subjects with Severe Congestive Heart Failure, NYHA class 4.

- Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated
arrhythmia status

9. Severe cerebrovascular disease (CVA within last 6 months)

10. Severe hypertension (diastolic BP > 100 on medication)

11. Patients with standard contraindications for MR imaging such as non-MRI compatible
implanted metallic devices including cardiac pacemakers, size limitations, etc.

12. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or
Magnevist) including advanced kidney disease

13. Patients with an active infection or severe hematological, neurological, or other
uncontrolled disease.

14. KPS Score < 60 (See "Definitions" below)

15. Patients unable to communicate with the investigator and staff.

16. Individuals who are not able or willing to tolerate the required prolonged stationary
position during treatment (approximately 2 hrs.)

17. Are participating or have participated in another clinical trial for the palliation
of their targeted bone metastasis tumors in the last 30 days

18. Patients receiving new chemotherapy regime or radiation to the targeted lesion (s)
within the last two weeks

19. Patients with persistent undistinguishable pain (pain source unidentifiable)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Evaluate incidence and severity of adverse events associated with ExAblate MRgFUS ExAblate Conformal system used in the palliation of pain due to metastatic bone tumors

Outcome Time Frame:

3 months post treatment

Safety Issue:



Israel: Ministry of Health

Study ID:




Start Date:

March 2010

Completion Date:

September 2013

Related Keywords:

  • Bone Cancer
  • Bone Metastases
  • Pain
  • Bone cancer
  • Bone Metastases
  • pain palliation
  • metastasis
  • breast cancer
  • lung cancer
  • prostate cancer
  • cancer related pain
  • tumors
  • Bone Neoplasms
  • Osteosarcoma
  • Neoplasm Metastasis
  • Bone Marrow Diseases