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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theraclion
ClinicalTrials.gov Identifier:
NCT01765907
First received: January 9, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Bone Metastasis
Device: HIFU
Phase 1

Study Type: Interventional
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).

Resource links provided by NLM:


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 ]

Enrollment: 3
Study Start Date: December 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIFU 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765907

Locations
France
Institut Gustave Roussy
Villejuif, France, 94275
Sponsors and Collaborators
Theraclion
  More Information

No publications provided

Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT01765907     History of Changes
Other Study ID Numbers: HIFU/F/BM/Feb2012.
Study First Received: January 9, 2013
Last Updated: April 15, 2014
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Bone Marrow Diseases
Bone Neoplasms
Neoplasm Metastasis
Bone Diseases
Hematologic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014