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

Bone Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765907
• Other study ID #: HIFU/F/BM/Feb2012.
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2013
• Last updated: April 15, 2014
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Theraclion
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: AFSSAPS
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastasis
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

Device:
• HIFU

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Theraclion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes