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

Kidney or Liver Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586235
• Other study ID #: 06-002982
• Secondary ID: 06-002982
• Status: Completed
• Start date: February 2007
• Est. completion date: June 2011

Study information

• Verified date: May 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney or Liver Tumors
• Liver Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Siemens Medical Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials