Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization

Mayo Clinic80 enrolled

Overview

Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization. Optimize image fusion algorithms for use in goal. Develop registration algorithms that result in maximal lesional overlap with a clinically relevant difference in an epicenter location of ≤ 2 cm for lesional identification and, ultimately ≤ 0.3 cm for interventional procedures.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Kidney or Liver Tumors

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Focal lesion involving the liver or kidney bases on CT or MRI Imaging * Liver lesion size \>5 mm and \<5 cm in diameter or renal lesion size is \>5 mm and \<4 cm in diameter * Age \>18 years old * Patient has provided written informed consent Exclusion Criteria: * Patient with cardiac pacemaker or defibrillator * Pregnant or lactating woman * Patient with severe IV contrast allergy (previous reaction to IV contrast not mitigated by appropriate premedication) * Patient unable to give informed consent

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Primary Endpoints: Global Fiducial Registration Error (FRE) of real-time US and fused CT images, Target Registration Error (TRE) and distance between lesional epicenters of real-time US and fused CT images.

Time frame: 2 years

Secondary Outcomes

Secondary Endpoint: Number of coregistration attempts to realize separation of lesional epicenters of real-time US and fused CT images of ≤2 cm and the number of attempts to realize a separation of ≤0.3 cm.

Time frame: 2 years

Data from ClinicalTrials.gov

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