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

NCT ID: NCT01765907

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-03-31

Brief Summary

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

Detailed Description

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

Conditions

Bone Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HIFU

Group Type: EXPERIMENTAL

HIFU

Intervention Type: DEVICE

Interventions

HIFU

Intervention Type: DEVICE

Eligibility Criteria

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.

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theraclion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

HIFU/F/BM/Feb2012.

Identifier Type: -

Identifier Source: org_study_id