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


N/A
18 Years
N/A
Not Enrolling
Both
Kidney or Liver Tumors

Thank you

Trial Information

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.

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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Matthew R. Callstrom, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

06-002982

NCT ID:

NCT00586235

Start Date:

February 2007

Completion Date:

June 2011

Related Keywords:

  • Kidney or Liver Tumors
  • Fusion
  • Ultrasound
  • Computed tomography
  • Liver Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905