Trial Search Results
ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain
The purpose of this study is to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.
Stanford is currently not accepting patients for this trial.
- Device: ExAblate 2100
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. One to 3 painful lesions.
5. 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)
6. Patients with persistent distinguishable pain associated with up to 3 tumors of which
a maximum of 2 tumors will be treated:
o If patient has pain from additional sites that are not planned for treatment, the
pain from the additional sites must be evaluated as being less intense by at least 2
points on the NRS compared to the site(s) to be treated.
7. Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors (i.e: both tumors
targeted for treatment must have NRS ≥ 4) irrespective of medication
8. Targeted tumors (most painful) size up to 8 cm in diameter
9. Patient whose targeted (most painful) tumors are on bone and bone-lesion interface is
deeper than 1cm from the skin.
10. Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate
MRgFUS device accessible
11. Able to communicate sensations during the ExAblate MRgFUS treatment
12. At least 2 weeks since chemotherapy
13. No radiation therapy to targeted (most painful) tumors in the past two weeks
1. Patients who either
- Need surgical stabilization of the affected weight bearing bony structure (>7
fracture risk score, see Section 6.9) OR
- Targeted tumor is at an impending fracture site of the weigh bearing bone (>7 on
fracture risk score, see Section 6.9).
o Patients with surgical stabilization of tumor site with metallic hardware
2. More than 3 painful lesions or more than 2 requiring immediate localized treatment
3. The targeted tumor(s) is (are) less than 2 points more painful compared to other
non-targeted painful lesions on the site specific NRS.
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. Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within six months of protocol
- Congestive heart failure requiring medication (other than diuretic)
- Patients on anti-arrhythmic drugs
9. Severe hypertension (diastolic BP > 100 on medication)
10. Patients with standard contraindications for MR imaging such as non-MRI compatible
implanted metallic devices including cardiac pacemakers, size limitations, etc.
11. Patients with an active infection or severe hematological, neurological, or other
12. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or
Magnevist) including advanced kidney disease
13. KPS Score < 60 (See "Definitions" below)
14. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
15. Individuals who are not able or willing to tolerate the required prolonged stationary
position during treatment (can be up to 4 hrs of total table time.)
16. Target (most painful) tumor-bone interface is less then 1cm from nerve bundles, bowels
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 chemotherapy or radiation (i.e., to the targeted lesion (s)) within
the last two weeks
19. Patients unable to communicate with the investigator and staff.
20. Patients with persistent undistinguishable pain (pain source unidentifiable)
21. Targeted (most painful) tumors size > 8 cm in diameter
22. Targeted (most painful) tumors:
- NOT visible by non-contrast MRI, OR
- NOT accessible to ExAblate device
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study