Kidney or Liver Tumors Clinical Trial
Official title:
Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization
NCT number | NCT00586235 |
Other study ID # | 06-002982 |
Secondary ID | 06-002982 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2007 |
Est. completion date | June 2011 |
Verified date | May 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Siemens Medical Solutions |
United States,
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 |