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

This study has been completed.
Sponsor:
Collaborator:
Siemens Medical Solutions
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586235
First received: December 21, 2007
Last updated: May 25, 2012
Last verified: May 2012
History of Changes

December 21, 2007
May 25, 2012
February 2007
June 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00586235 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
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Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization
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.

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients with kidney or liver tumors
Kidney or Liver Tumors
Not Provided
1
patients with indeterminate kidney or liver lesions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00586235
06-002982, 06-002982
Yes
Dr. Matthew Callstrom, Mayo Clinic- Rochester, MN
Mayo Clinic
Siemens Medical Solutions
Principal Investigator: Matthew R. Callstrom, MD, PhD Mayo Clinic
Mayo Clinic
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP