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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT01965002
Eligibility Criteria:
INCLUSION CRITERIA
* ≥ 10 years of age.
* Benign or malignant soft tissue tumors of the extremities, flanks, pelvis, or shoulders requiring surgical intervention.
* Tumor must not have been treated previously with radiation.
* Targeted tumor(s) are accessible to the ExAblate device
* Targeted volume within the tumor is located deeper than 1 cm from the skin
* Targeted tumor is clearly visible by non-contrast magnetic resonance imaging (MRI)
* Karnofsky Performance Status \> 60
* Normal platelet count and coagulation profile
* Glomerular filtration rate \> 60 mL/min
* Able to safely undergo MRI exam and receive mild sedation for the treatment.
* Able to tolerate being in the MRI scanner for the duration of the study.
* Able and willing to give consent (or consent + assent where applicable), and able to attend all study visits.
EXCLUSION CRITERIA
* Previous radiation treatment to the tumor.
* Currently receiving dialysis.
* Acute medical condition (eg, pneumonia, sepsis) expected to hinder completion of the study
* 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
* Severe hypertension (diastolic BP \> 100 on medication)
* Contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, etc
* Severe hematologic, neurologic, or other uncontrolled disease
* Known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine)
* Known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease
* Pregnant and nursing
* Karnofsky Performance Score \< 60
* Severe cerebrovascular disease \[cardiovascular accident (CVA) within 6 months\]
* Not able or not willing to tolerate the required prolonged stationary position during treatment (up to 5 hrs of total table time)
* Target volume in tumor is less than 1 cm from neurovascular bundles, major blood vessels, bowel, or bladder.
* Targeted tumors:
* NOT visible by non-contrast MRI, OR
* NOT accessible to ExAblate device
* Not a candidate for either regional anesthesia or mild sedation
* Not be participating in another trial testing other investigational agents or devices
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT01965002
Study Brief:
Protocol Section:
NCT01965002