Evaluation of Image-Guided Liver Surgical System for Resection of Liver Cancer

January 25, 2011 updated by: Pathfinder Therapeutics
Image-guided surgery essentially describes the interactive use of medical images during a surgical procedure and is often referred to as a "global positioning" system (GPS) for surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

In an automobile GPS, the current position of a vehicle is accurately localized or "registered" onto an electronic roadmap located on the dashboard. As the automobile moves, its position is updated on this roadmap. The driver can use the GPS as a guide to determine where the vehicle has been and where it is headed. This same concept is applied during image-guided surgery, as the current surgical position of instruments in the operating room is registered onto medical images of the patient acquired preoperatively. These images are used as a guide by the surgeon for more accurate localization of tumors and other surrounding anatomic structures. This clinical trial is designed to determine the effectiveness of using image-guided techniques for the treatment of liver tumors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

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
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Department of Surgery
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants receiving surgery for Liver disease.

Description

Inclusion Criteria:

  1. Written informed consent must be obtained.
  2. Patient must be 18 years or older.
  3. Patients recruited are male or non-pregnant, non-lactating females. Liver resection or ablation could be harmful to an unborn child, and therefore is not recommended during pregnancy. All consented patients of childbearing potential will be advised to use adequate birth control (oral, implanted, or barrier methods), along with their sexual partners, while being considered for liver tumor resection or ablation and one month following surgery.
  4. Negative serum or urine pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility).
  5. Patients enrolled must be candidates for surgical liver resection of liver cancer (primary or metastatic) or benign liver lesions (hemangioma, Focal Nodular Hyperplasia, Adenoma). Liver cancer must be present on preoperative imaging study (CT and/or MRI), if applicable.

  6. Patient must be scheduled for surgical treatment of the liver cancer requiring the removal of at least one (1) anatomic segment.

    -

Exclusion Criteria:

  1. Any condition which, in the judgment of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
  2. Patients that have a mental condition rendering them unable to understand informed consent to the nature, scope, and possible consequences of this study.
  3. Patients requiring surgical intervention that extends beyond the liver, with the exception that extension into some adjacent structures might be allowed unless the liver is not the primary focus of the surgery AND the potential blood loss from the other surgical sites may jeopardize the safety of the patient. There is no absolute rule as to what adjacent structures would be allowed, thus prior approval must be obtained from the Medical Monitor listed above for all extrahepatobiliary surgery.
  4. Patients with hereditary hematologic/coagulation disorders unrelated to their liver disease.
  5. Patients with cirrhosis of the liver classified as Child's B or C. (See Appendix A)
  6. Use of aspirin within 7 days prior to surgery or antiplatelet agents (i.e., Plavix) within 10 days prior to surgery or nonsteroidal anti-inflammatory medications within 48 hours prior to surgery.
  7. Patients with thrombocytopenia (platelet counts below 100,000 per ml, White Count 3.0, Hemoglobin 10 or greater).
  8. Patients who are currently (within the last 30 days prior to surgery) participating in another clinical trial with any investigational drug or device.
  9. Patients undergoing liver surgery as a result of trauma.
  10. Patients undergoing liver surgery for the purpose of receiving a liver transplant.
  11. Patients undergoing liver surgery in which there is a single minor wedge resection on the surface of the liver.

  12. Patients with established renal insufficiency (defined as creatinine greater than 2.5 mg/dl), or a condition that requires hemodialysis.

    -

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The overall purpose of this NIH-funded study is to evaluate the effectiveness of image-guided liver surgery by measuring variables before, during and following surgery.
Time Frame: 24 Months
24 Months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pathfinder Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Geller, M.D., UPMC Liver Cancer Center
  • Principal Investigator: Alan Hemming, M.D., University of Florida Department of Surgery

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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PTI-LC-2007-01
  • R44CA119502 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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