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

NCT01765907 | Completed Phase 1

• 1 other identifier: HIFU/F/BM/Feb2012.
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound (HIFU).

Conditions

Bone Metastasis

Outcome Measures

Primary Outcomes (1)

• 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)

  up to 3 months after HIFU session

Study Arms (1)

HIFU

EXPERIMENTAL

Device: HIFU

Interventions

HIFU DEVICE

HIFU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient with social security coverage.

You may not qualify if:

• 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

Sponsors & Collaborators

• Theraclion: lead

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94275, France

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 10, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

FR (1)