Clinical trial · Interventional
Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
A Feasibility Study to Evaluate the Safety and Effectiveness of ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound Treatment of Soft Tissue Tumors of the Extremities
NCT01965002CI-TRIAL-00033068terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual factor
Summary
Brief summary (as posted)
The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) surgery in the treatment of soft tissue tumors of the extremities.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Neoplasms | Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin | Drug | Aspirin | ALIAS |
| Enoxaparin | Drug | — | UNRESOLVED |
| MRgHIFU | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRgHIFU
- description
- The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue. The treatment process begins with the physician acquiring a set of MR images, identifying 1+ target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours. The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time. MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment. The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated. About 100 individual sonications can be delivered over a 3-hour period to complete a treatment.
- interventionNames
- Device: MRgHIFU
- Drug: Aspirin
- Drug: Enoxaparin
Primary outcomes (1)
- measure
- Overall Safety - Incidence of Any Device-related Adverse Events
- timeFrame
- 1 week
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.