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Completed

NCT Number: NCT00586235

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

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.

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Key information

Conditions

Kidney or Liver Tumors Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Siemens Medical Solutions

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 4, 2008
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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