ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain

Multiple Myeloma Clinical Trial

Official title:

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic and Multiple Myeloma Bone Tumors for the Palliation of Pain in Patients Who Are Not Candidates for Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656305
• Other study ID #: BM004
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: September 2012

Study information

• Verified date: January 2020
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion criteria:

1. Men and women age 18 and older

2. Patients who are able and willing to give consent and able to attend all study visits

3. Patients who are suffering from symptoms of bone metastases or multiple myeloma bone lesions and are radiation failure patients:

Radiation failure candidates are those who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician, those for whom their treating physician would not prescribe radiation or additional radiation treatments, and those patients who refuse additional radiation therapy,

4. Patients who refuse other accepted available treatments such as surgery or narcotics for pain alleviation.

5. Patient with NRS (0-10 scale) pain score = 4 irrespective of medication

6. Targeted tumor(s) are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5)

7. Targeted tumor (treated) size up to 55 cm2 in surface area

8. Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.

9. Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible

10. Able to communicate sensations during the ExAblate treatment

11. Patients on ongoing chemotherapy regimen for at least 1 month at the time of eligibility:

• with same chemotherapy regimen (as documented from patient medical dossier),

And

• Worst pain NRS still >= 4

And

• do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study.

12. No radiation therapy to targeted (most painful) lesion in the past two weeks

13. Bisphosphonate intake should remain stable throughout the study duration.

14. Patients will have from 1 to 5 painful lesions and only the most painful lesion will be treated.

15. Patients with persistent distinguishable pain associated with 1 site to be treated (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the NRS compared to the site to be treated).

Exclusion Criteria:

1. Patients who either

• Need surgical stabilization of the affected bony structure (>7 fracture risk score, see Section 7.3) OR

• Targeted tumor is at an impending fracture site (>7 on fracture risk score, see Section 7.3).

OR

• Patients with surgical stabilization of tumor site with metallic hardware

2. More than 5 painful lesions, or more than 1 requiring immediate localized treatment

3. Targeted (treated) tumor is in the skull

4. Patients on dialysis

5. Patients with life expectancy < 3-Months

6. patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.

7. Patients with unstable cardiac status including:

• Unstable angina pectoris on medication

• Patients with documented myocardial infarction within six months of protocol entry

• Congestive heart failure requiring medication (other than diuretic)

• Patients on anti-arrhythmic drugs

8. Severe hypertension (diastolic BP > 100 on medication)

9. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >250 pounds), etc.

10. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.

11. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease

12. KPS Score < 60 (See "Definitions" below)

13. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

14. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)

15. Target (treated) tumor is less then 1cm from nerve bundles, bowels or bladder.

16. Are participating or have participated in another clinical trial in the last 30 days

17. Patients initiating a new chemotherapy regime, or radiation (for the targeted most painful lesion) within the last 2 weeks

18. Patients unable to communicate with the investigator and staff.

19. Patients with persistent undistinguishable pain (pain source unidentifiable)

20. Targeted (treated) tumor surface area >= 55 cm2

21. Patient whose bone-lesion interface is < 10-mm from the skin

22. Targeted (treated) tumor NOT visible by non-contrast MRI,

23. Targeted (most painful) tumor Not accessible to ExAblate

24. The targeted tumor is less than 2 points more painful compared to other painful lesions on the site specific NRS.

Related Conditions & MeSH terms

• Bone Metastases
• Multiple Myeloma
• Neoplasm Metastasis
• Neoplasms, Plasma Cell

Intervention

Device:
• ExAblate MRfFUS
MR guided focused ultrasound.
• Sham
sham comparator

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
Israel	Rambam medical Center -The Pain palliation unit	Haifa
Israel	Sheba Medical Center	Tel Hashomer
Italy	University of Rome "La Sapienza"	Rome
Russian Federation	Rostov State Research Institute of Oncology	Rostov on Don
Russian Federation	N. N. Petrov Institute of Oncology	St. Petersburg
United States	University MRI & Diagnostic Imaging Centers	Boca Raton	Florida
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of California San Diego	La Jolla	California
United States	Weill Cornell Medical College	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Stanford University Medical Center	Stanford	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Italy,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Responders	Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), each subject was rated as a Responder or Non-responder. A responder is defined as a subject with a reduction in NRS worst score from baseline of two (2) or more points, and no increase in pain medication use.	3 months post treatment
Secondary	Number of Participants With a Change in Medication Use	Medication Use change reported from baseline until of study. Medication use is quantified by "morphine equivalent usage" (measured separately from Responder/Non-responder definition for the primary endpoint)	3 months post treatment
Secondary	Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline	The BPI-QOL questionnaire is designed to show the severity and interference of pain in the lives of patients. This is a 7-item questionnaire that asks respondents the extent to which pain interferes with their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life using a 0-10 numerical rating scale in which 0 represents 'does not interfere' and 10 indicates 'completely interferes'. Responses to the 7 items are averaged to form the pain interference scale score. Lower scores are better, showing less interference in daily activities while higher scores show more interference and hence worse outcomes.	3 months post treatment