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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00586235

Enrollment

Registered

2008-01-04

Start date

2007-02-28

Completion date

2011-06-30

Last updated

2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney or Liver Tumors

Keywords

Fusion, Ultrasound, Computed tomography

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results