Trial Information

Antalgic Treatment of Painful Bone Metastases by US-guided High Intensity Focused Ultrasound (HIFU).

Inclusion Criteria

- 18 years of age or older.

- Histologically proven malignancy of primary tumor. Histologic diagnosis may be
established from needle biopsy, cytology, or a surgical biopsy or resection. If the
nature of the lesion has been previously through biopsy, the lesion to be treated does
not require further documentation.

- Metastatic disease documented either by imaging techniques (plain radiographs,
radionuclide bone scans, computed tomography scans and magnetic resonance imaging) or
by histology. Other imaging techniques may be acceptable with the approval of the
principal investigator.

- ≤ 3 treatable painful bone metastases.

- "Worst Pain Score" of > 3 on a scale of 10 during a 24-hour period (as scored on the
Brief Pain Inventory [BPI] question #3: 0 = no pain; 10 = worst possible pain) despite
level II analgesic medications.

- Prothrombin time (PT) >50%, Thrombocytes >50x109/L.

- Estimated life expectancy of 3 months or greater, as estimated by the responsible
clinician.

- Targeted tumor clearly visible in B-mode ultrasonography, and accessible to US-HIFU
treatment, based on imaging data.

- Agreement from the anaesthetist for a IV conscious sedation

- Signed study-specific informed consent prior to inclusion.

- Negative pregnancy test before inclusion for women of childbearing and or efficient
method of contraception.

- Patient with social security coverage. Biphosphonate, chemotherapy or hormone therapy
intake should remain stable (if possible) throughout follow-up duration.

Exclusion criteria for subject selection

- Pregnant or lactating women.

- Radiation therapy to the targeted sites within 30 days prior to enrollment.

- Targeted tumor mass is less than 10 mm from spinal cord, nerve bundles, bladder, bowel,
or hollow viscera,

- Targeted tumor located in skull (including facial bones), vertebral body or sternum.

- Site at need for surgical stabilization

- Uncontrolled bleeding disorders.

- Hematologic primary malignancies.

- patient participating in other trials using drugs or devices