Antalgic Treatment of Painful Bone Metastases by US-guided High Intensity Focused Ultrasound (HIFU)
This study is currently recruiting participants.
Verified January 2013 by Theraclion
Information provided by (Responsible Party):
First received: January 9, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound (HIFU).
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Antalgic Treatment of Painful Bone Metastases by US-guided High Intensity Focused Ultrasound (HIFU).|
Further study details as provided by Theraclion:
Primary Outcome Measures:
- To assess safety including adverse and serious adverse events, local and systemic tolerance of HIFU in patients with bone metastasis acoording to the Common Terminology Criteria for Adverse events (CTCAE version 4.3) [ Time Frame: up to 3 months after HIFU session ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765907
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, 94275|
|Contact: Thierry DE BAERE, Professor - MD 01 42 11 54 28 email@example.com|
|Principal Investigator: Thierry De Baere, Professor-MD|
Sponsors and Collaborators