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
  Purpose

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.


Condition
Kidney or Liver Tumors

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: February 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients with indeterminate kidney or liver lesions

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with kidney or liver tumors

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586235

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Siemens Medical Solutions
Investigators
Principal Investigator: Matthew R. Callstrom, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Dr. Matthew Callstrom, Mayo Clinic- Rochester, MN
ClinicalTrials.gov Identifier: NCT00586235     History of Changes
Other Study ID Numbers: 06-002982, 06-002982
Study First Received: December 21, 2007
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Fusion
Ultrasound
Computed tomography

ClinicalTrials.gov processed this record on October 23, 2014