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:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT03547557
Eligibility Criteria:
Inclusion Criteria:
1. Men and women age 18 and older
2. Patients who are able and willing to give written consent and are 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. Patients with persistent pain from at least one site of bone metastases and are able to distinguish the pain from other painful sites oPatient with localized VAS pain score ≥ 4, at the target tumor oIn case of patients with more than one painful site, VAS pain score at the target site should exceed VAS pain score at any other site by at least two units.
5. 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)
6. Targeted tumor(s) size is smaller than 8 cm in diameter on bone surface
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. KPS ≥60 (See "Definitions" below)
11. At least 2 weeks since chemotherapy
12. 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 impending fracture
4. Patients with unstable cardiac status including:
* Unstable angina pectoris on medication oPatients with documented myocardial infarction within six months of protocol entry oCongestive heart failure requiring medication (other than diuretic) oPatients on anti-arrhythmic drugs
5. Severe hypertension (diastolic BP \> 100 on medication)
6. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations; weight \>110 kg, etc.
7. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist)
8. Extensive scarring in an area in the path of energy planned passage to the treatment area
9. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
10. Patients on anti-coagulation therapy or those with an underlying bleeding disorder
11. Severely abnormal coagulation (INR\>1.5)the upper limit
12. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
13. Patients with life expectancy \< 6-Months
14. Patients with surgical stabilization of tumor site with metallic hardware
15. Lesion is less then 5mm from a nerve.
16. Pregnant or lactating women
17. Patients that are currently participating or have participated in another clinical trial in the last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03547557
Study Brief:
Protocol Section:
NCT03547557