Overview

This trial is active, not recruiting.

Condition soft tissue neoplasms
Treatment exablate magnetic resonance imaging guided high intensity focused ultrasound (mrghifu)
Phase phase 1/phase 2
Sponsor Pejman Ghanouni
Start date May 2014
End date August 2016
Trial size 30 participants
Trial identifier NCT01965002, 26667, VAR0095

Summary

The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate MR guided focused ultrasound surgery in the treatment of soft tissue tumors of the extremities.

United States California
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
exablate magnetic resonance imaging guided high intensity focused ultrasound (mrghifu)

Primary Outcomes

Measure
Safety determined by evaluating for the incidence and severity of any device related complication
time frame: Up to 1 week

Secondary Outcomes

Measure
Percent successful ablation or non-perfused volume (NPV)
time frame: Up to 1 week
Accuracy of ablation volume within the tumor
time frame: Up to 1 week

Eligibility Criteria

Male or female participants at least 10 years old.

Inclusion Criteria: 1. Males and females at least 10 years of age. 2. Patients who have benign or malignant soft tissue tumors of the extremities, flanks, pelvis, or shoulders that require surgical intervention. 3. Tumor must not have been treated previously with radiation. 4. Patients (or guardians/parents) who are able and willing to give consent (and assent where applicable) and able to attend all study visits. 5. Able to safely undergo MRI exam and receive mild sedation for the treatment. 6. Patient is able to tolerate being in the MRI scanner for the duration of the study. 7. Targeted tumor(s) are accessible to the ExAblate device 8. Patients in whom the targeted volume within the tumor is located deeper than 1 cm from the skin 9. Targeted tumor is clearly visible by non-contrast MRI 10. Karnofsky Performance Status > 60 11. Normal platelet count and coagulation profile 12. Glomerular filtration rate > 60 ml/min Exclusion Criteria: 1. Previous radiation treatment to the tumor. 2. Patients on dialysis. 3. Patients with acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study 4. Patients with unstable cardiac status including: 1. Unstable angina pectoris on medication 2. Patients with documented myocardial infarction within six months of protocol entry 3. Congestive heart failure requiring medication (other than diuretic) 4. Patients on anti-arrhythmic drugs 5. Severe hypertension (diastolic BP > 100 on medication) 6. Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, etc 7. Patients with severe hematologic, neurologic, or other uncontrolled disease 8. Known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine) 9. Known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease a. Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients 10. Karnofsky Performance Score < 60 11. Severe cerebrovascular disease (multiple CVAs or CVA within 6 months) 12. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 5 hrs of total table time) 13. Target volume in tumor is less then 1cm from neurovascular bundles, major blood vessels, bowel or bladder. 14. Targeted tumors: - NOT visible by non-contrast MRI, OR - NOT accessible to ExAblate device 15. Patient not candidate for either regional anesthesia or mild sedation 16. Patient should not be part of another trial testing other Investigational Agents or Devices

Additional Information

Official title 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
Principal investigator Raffi Avedian
Description Objectives include assessment of the incidence and severity of adverse events associated with treatment, and the accuracy of ablation by comparing the measured volume treated based on MR thermometry and post-contrast non-perfused tissue calculations to the actual treated volume in the resected tumor. In addition, the tissue adjacent to the treated region within the tumor but outside the gross limits of the ablation will be examined histologically for evidence of thermal damage.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Stanford University.
Location data was received from the National Cancer Institute and was last updated in July 2016.