NCT01117246

Brief Summary

This study is to confirm the safety and technical of MRI guided High Intensity Focused Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases. MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue. The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

1.2 years

First QC Date

May 3, 2010

Last Update Submit

February 17, 2012

Conditions

Secondary Malignant Neoplasm of Bone

Keywords

bone metastasispain palliation

Outcome Measures

Primary Outcomes (3)

  • Technical efficacy by medication and pain score

    Technical efficacy of HIFU for treatment of bone metastasis as assessed by a change in the medication and pain scores

    0, 2, 7, 14, 30, 90 days

  • Safety of treatment

    Safety of HIFU for treatment of the bone metastasis as determined by adverse event reporting

    0-90 days

  • Safety determined by intended lesions

    Safety of HIFU for treatment of the bone metastasis as determined by formation of intended lesions.

    0-90 days

Secondary Outcomes (4)

  • Treatment size

    0-90 days

  • X-Ray treatment size measurements

    0-90 days

  • Length of Hospital Stay

    0-90 days

  • Quality of Life

    0, 7, 14, 30, 90 days

Study Arms (1)

Treated bone metastasis

EXPERIMENTAL

Patients with bone metastasis causing pain.

Device: High Intensity Focused Ultrasound

Interventions

High Intensity Focused UltrasoundDEVICE

HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein and nerve denaturation, irreversible cell damage, and coagulative necrosis.

Also known as: • HIFU, • Ablation, • High Intensity Focused Ultrasound
Treated bone metastasis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged \> 18 years
  • Covered by social security insurance
  • Patient able to give consent and able to attend
  • study visit
  • Weight \< 140kg
  • Patient with bone metastases
  • Pain localized on bone metastases to be treated with NRS (0-10 scale) pain score 4 irrespective of medication
  • Targeted tumor accessible for MR-HIFU treatment
  • The maximum size of the bone metastases smaller than 8cm in diameter
  • Targeted tumor visible by non contrast MRI
  • Interface between bone and skin deeper than 10 mm
  • Able to communicate sensation during treatment
  • Treatment day must be planned at least 2 weeks after any treatment of the primary tumor, chemotherapy or RT treatment of a bone targeted for HIFU

You may not qualify if:

  • Patient enrolled in another clinical study related to bone metastases or pain relief treatment
  • Pregnant or nursing woman
  • Need of surgical stabilization or site at risk of
  • fracture
  • More than one painful lesion per treatment
  • Patients who are not able to tolerate required stationary position during treatment
  • HIFU targeted tumor in contact with hollow viscera
  • Targeted tumor less than 1 cm to nerve bundles, bladder and bowel
  • Targeted tumor located in skull, spine (excepted sacrum) or sternum.
  • MRI or contrast agent contraindicated
  • Severe Cardiovascular, neurological, renal or hematological chronic disease
  • Active infection
  • Scar in the beam path
  • Orthopedic implant at the site of treatment
  • Previous surgery at the site of treatment Patient history, MRI exam
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital St. André

Bordeaux, France

Location

Related Publications (1)

  • Chow E, Wu JS, Hoskin P, Coia LR, Bentzen SM, Blitzer PH. International consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Radiother Oncol. 2002 Sep;64(3):275-80. doi: 10.1016/s0167-8140(02)00170-6.

    PMID: 12242115BACKGROUND

MeSH Terms

Interventions

High-Intensity Focused Ultrasound Ablation

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Hervé Trillaud, Professor

    Hôpital St. André, Service de Radiologie

    PRINCIPAL INVESTIGATOR

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

May 3, 2010

First Posted

May 5, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

FR(1)