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

NCT00782886 | Completed DMC

• 2 other identifiers: PTI-LC-2007-01R44CA119502
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Liver Cancer

Keywords

Pathfinder; Liver; Resection; Surgery; To evaluate the effectiveness of image-guided liver surgery by measuring variables before, during and following surgery.; Completeness of resection and the accuracy of the resection, as determined by preoperative predicted RLV

Outcome Measures

Primary Outcomes (1)

• 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.

  24 Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants receiving surgery for Liver disease.

You may qualify if:

• Written informed consent must be obtained.
• Patient must be 18 years or older.
• 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.
• Negative serum or urine pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility).
• 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.
• Patient must be scheduled for surgical treatment of the liver cancer requiring the removal of at least one (1) anatomic segment.

You may not qualify if:

• 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.
• Patients that have a mental condition rendering them unable to understand informed consent to the nature, scope, and possible consequences of this study.
• 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.
• Patients with hereditary hematologic/coagulation disorders unrelated to their liver disease.
• Patients with cirrhosis of the liver classified as Child's B or C. (See Appendix A)
• 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.
• Patients with thrombocytopenia (platelet counts below 100,000 per ml, White Count 3.0, Hemoglobin 10 or greater).
• Patients who are currently (within the last 30 days prior to surgery) participating in another clinical trial with any investigational drug or device.
• Patients undergoing liver surgery as a result of trauma.
• Patients undergoing liver surgery for the purpose of receiving a liver transplant.
• Patients undergoing liver surgery in which there is a single minor wedge resection on the surface of the liver.
• Patients with established renal insufficiency (defined as creatinine greater than 2.5 mg/dl), or a condition that requires hemodialysis.

Sponsors & Collaborators

• Pathfinder Therapeutics: lead
• National Institutes of Health (NIH): collaborator

Study Sites (3)

University of Florida Department of Surgery

Gainesville, Florida, 32610, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Pathfinder Therapeutics
• Medelis Inc. (CRO)

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• David Geller, M.D.

  UPMC Liver Cancer Center

  PRINCIPAL INVESTIGATOR

• William Jarnagin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Alan Hemming, M.D.

  University of Florida Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 31, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 27, 2011

Record last verified: 2011-01

Locations

US (3)