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

Completed

• Conditions: Kidney or Liver Tumors

• Registration Number: NCT00586235
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	2 years

Secondary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States