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

NCT ID: NCT00586235

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney or Liver Tumors

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

patients with indeterminate kidney or liver lesions

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Medical Solutions

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Matthew R. Callstrom

Study Prinicple Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew R. Callstrom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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06-002982

Identifier Type: -

Identifier Source: secondary_id

06-002982

Identifier Type: -

Identifier Source: org_study_id

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