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Clinical Application of Image Guided Liver Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00878215
First received: April 7, 2009
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

Image-guided surgery is a new technology, which is used to create 3-D pictures that generate a map of the liver. This map will allow surgeons to know the exact anatomical location of their instruments, including instances when direct visualization is not possible. This study is designed to determine the safety and feasibility of using image-guided techniques for treatment of liver tumors. The overall goal of this study is to use image-guided surgery for the improvement of the surgeon's ability to remove liver tumors.


Condition Intervention
Hepatocellular Cancer
Procedure: Phase 1-4,To localize anatomical points on the liver surface

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Application of Image Guided Liver Surgery

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To reach success in complete ablation of liver cancer tumors as well as no recurrence of the tumor within 6 months. [ Time Frame: no recurrence of tumor within 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The accuracy of image-guided surgery and laser range scanning in hepatic surgery [ Time Frame: completion of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: December 2002
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1
The objective of phase 1 is to localize anatomical points on the liver surface using image-guided surgery and laser range scanning. The specific endpoint of this phase will be reached when we perform 10 successful intraoperative registrations with no more than a 30% failure rate over all the cases.
Procedure: Phase 1-4,To localize anatomical points on the liver surface
The objectives of phase 1 are complete. Phases 2 and 3 will enroll concurrently. If the objectives of any phase are not met, then the study will be discontinued and postponed and the experimental protocol will be revised.
Experimental: Phase 2
The objective of phase 2 is to determine the accuracy with which image guided surgery (IGS) can be used to implant a ceramic bead inside a tumor. After the ceramic bead is implanted using IGS, the tumor will be removed with standard surgical resection methods and analyzed using imaging. The specific endpoint of this phase is to achieve delivery of the bead to within 8mm of the pre-operatively planned target point. If we are unable to insert the ceramic bead due to technical or anatomical difficulty, we will consider this a screen failure.
Procedure: Phase 1-4,To localize anatomical points on the liver surface
The objectives of phase 1 are complete. Phases 2 and 3 will enroll concurrently. If the objectives of any phase are not met, then the study will be discontinued and postponed and the experimental protocol will be revised.
Experimental: phase 3
The objective of phase 3 is to ascertain the target accuracy of an ablation probe using image-guided surgery technology. After the ablation procedure, tumors will be removed with standard resection procedures and analyzed using pathology. The specific endpoint of this phase is to achieve an ablation burn within a 5 mm radius of the tumor centroid. A measurement of the ablation probe placement via the burn zone will be performed by pathology via specimen sectioning.
Procedure: Phase 1-4,To localize anatomical points on the liver surface
The objectives of phase 1 are complete. Phases 2 and 3 will enroll concurrently. If the objectives of any phase are not met, then the study will be discontinued and postponed and the experimental protocol will be revised.
Experimental: Phase 4
The objective of Phase 4 is to perform ablation using image-guided surgery on tumors within patients who are not candidates for standard surgical resection. The specific endpoint is to reach a 90% success rate of complete ablation according to early post-ablative imaging studies as well as no recurrence of the tumor within 6 months.
Procedure: Phase 1-4,To localize anatomical points on the liver surface
The objectives of phase 1 are complete. Phases 2 and 3 will enroll concurrently. If the objectives of any phase are not met, then the study will be discontinued and postponed and the experimental protocol will be revised.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained.
  • Patient must be 18 years or older.
  • Are male or non-pregnant, non-lactating females. Liver resection or ablation could be harmful to an unborn child therefore, is not recommended during pregnancy. After informed consent is obtained, women of childbearing potential will be required to have a blood or urine pregnancy test. 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 at least up to a month following surgery.
  • Patients enrolled in Phase I must be candidates for surgical liver resection per a treating surgeon's discretion. Patients enrolled in Phase 2-3 must be candidates for surgical liver resection of liver mass. Patients enrolled in Phase 4 must be candidates for surgical ablation, but not candidates for surgical resection.
  • Patients are scheduled clinically for use of the Pathfinder Explorer Liver Image Guided System which is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

Exclusion Criteria:

  • Any condition which, in the judgment of the investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
  • Mental condition rendering the subject or his/her legal representative unable to understand informed consent to the nature, scope, and possible consequences of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878215

Contacts
Contact: William C Chapman, MD 314-362-2538 chapmanw@wustl.edu
Contact: Helen E Kaemmerer, BS,CCRC 314-362-3791 kaemmererh@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: William C Chapman, MD    314-362-2538    chapmanw@wudosis.wustl.edu   
Principal Investigator: William C Chapman, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: William C Chapman, MD Washington University Medical School
  More Information

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00878215     History of Changes
Other Study ID Numbers: 201104308
Study First Received: April 7, 2009
Last Updated: September 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Image Guided Liver Surgery

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2014