Clinical Trial on Kidney or Liver Tumors - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Kidney or Liver Tumors

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with kidney or liver tumors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1 patients with indeterminate kidney or liver lesions

What is the study measuring?

Primary Outcome Measures

Outcome 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. Time Frame: 2 years	2 years

Secondary Outcome Measures

Outcome 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. Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Siemens Medical Solutions

Investigators

Principal Investigator: Matthew R. Callstrom, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Mayo Clinic Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria