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

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

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

Study Overview

• Status: Completed
• Conditions: Bone Metastasis
• Intervention / Treatment: Device: 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

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Villejuif, France, 94275
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HIFU	Device: HIFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Theraclion

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: January 9, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (ESTIMATE): January 10, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 16, 2014
• Last Update Submitted That Met QC Criteria: April 15, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: HIFU/F/BM/Feb2012.