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Protocol No. OS12204
Principal Investigator Varghese, Tomy
Age Group Adult
Sponsor Type Externally Peer-Reviewed; Institutional
Title Electrode perturbation based elasticity imaging for ablation monitoring
Objective The purpose of the research is to test a new form of diagnostic imaging for treatment monitoring (strain, modulus and shear wave imaging) for liver tumor ablation. This imaging is considered investigational at this time as it is not approved by the Food and Drug Administration (FDA). The goal of this study is to determine how useful this experimental ultrasound information is when compared with the current standard of care ultrasound.
Treatment During liver tumor ablation, additional ultrasound scans of the liver tumor before and after ablation will be performed. During ablation, a small electrode or antenna is placed in the tumor. The electrode or antenna will be displaced by hand while a small vibrator device is used to vibrate the electrode.
Description Participants scheduled for a liver tumor ablation procedure using either radiofrequency or microwave ablation will be asked to get additional ultrasound scans of their liver tumor before and after the ablation procedure. This examination will be performed during the ablation procedure after the electrode or antenna has been placed in the tumor. A small displacement or vibration will be applied to the electrode or antenna of less than a millimeter. The displacement of the electrode will be done by hand by the clinician, while a small vibrator device will be used to vibrate the electrode. Participants will not feel the displacement or vibration of the electrode. No hospitalization is required, and no drugs will be administered for this procedure. Ultrasound scans from several positions might be involved, but the total time required for this study will likely be around 5 minutes each before and after the ablation procedure. This procedure will in no way interfere with any scheduled clinical activities (specifically ablation), and the results from the study procedure will not be used to make any treatment decisions. Information related to the liver tumor will be collected from participants' medical records and results of any related, X-ray CT biopsy or surgery will be recorded for purposes of this study. This information will be used to obtain a better understanding of the results obtained from the ultrasound exam.
Patients scheduled for a tumor ablation procedure in the liver
Liver tumors may be primary liver tumors or secondary (metastatic to the liver)
Applicable Disease Sites Liver
Participating Institutions UW Hospital and Clinics