Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT00350233
Eligibility Criteria:
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 with histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and or imaging techniques
4. Must have persistent pain from at least one site of bone metastases
* Patient with VAS pain score ≥ 4, when VAS test taken without medication, OR
* Patient taking pain-relieving medication for management of bone metastases.
5. Targeted tumor(s) are ExAblate device accessible
6. Targeted tumor(s) size is smaller than 8 cm in diameter
7. Patient whose lesion is on bone and is ≥ 10-mm from the skin.
8. Tumor(s) clearly visible by non-contrast MRI
9. Able to communicate sensations during the MRgFUS ExAblate treatment
10. At least 2 weeks since chemotherapy
11. At least 1 month since radiation therapy
Exclusion Criteria:
1. Diffuse skeletal tumoral spread as evaluated by imaging.
2. Patients who need pre-treatment surgical stabilization of the affected bony structure.
3. Targeted tumor is in weight bearing bones or impending fracture
4. Targeted tumor is in the vertebral column.
5. 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
6. Severe hypertension (diastolic BP \> 100 on medication)
7. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight \>250 pounds), etc.
8. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist)
9. ASA Score\>2 (See "Definitions" below)
10. Extensive scarring in an area in the path of energy planned passage to the treatment area
11. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
12. Patients on anti-coagulation therapy or those with an underlying bleeding disorder.
13. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.)
14. Patient whose lesion is \< 10-mm from the skin
15. Patients with \< 2-Weeks since chemotherapy
16. Patient with \< 1-Month since radiation therapy
17. Patients with life expectancy \< 6-Months
18. Patients with surgical stabilization of tumor site with metallic hardware
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00350233
Study Brief:
Protocol Section:
NCT00350233