Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2002-10-24
2011-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1:Localize Anatomical Points on Liver Surface
-The surgeon will use image-guided surgery equipment to create the mapping with 3-D pictures of the participants liver. Laser range scanning will also be used to take 3-D pictures of the liver surface. The participant will then have planned standard surgery.
Explorer Liver Image Guided System
Explorer Liver Passive Tracking
Liver surgery
-Standard of care
Phase 2: Ceramic bead
-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. During the surgery, a ceramic bead will be placed in a pre-operatively determined target location within the tumor using image-guided surgery. Standard surgical procedures will then be used to remove the tumors. Magnetic resonance (MR) images of the resected liver will confirm targeting accuracy.
Explorer Liver Image Guided System
Explorer Liver Passive Tracking
Liver surgery
-Standard of care
Phase 3: Ablative therapy
-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. The liver tumors will be ablated using image-guided surgery. Standard surgical procedures will then be used to remove the portion of the liver that has the ablated tumors. The accuracy of the ablation will be confirmed via pathology sectioning.
Explorer Liver Image Guided System
Explorer Liver Passive Tracking
Liver surgery
-Standard of care
Liver abalation
-Standard of care
Phase 4: Ablative therapy (not liver resection candidates)
-This phase is for patients who otherwise do not qualify to have a portion of their liver to be surgically removed. The surgeon will use image-guidance to create the mapping with 3-D pictures of the liver. The tumors will be ablated using image-guided therapy.
Explorer Liver Image Guided System
Explorer Liver Passive Tracking
Liver abalation
-Standard of care
Interventions
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Explorer Liver Image Guided System
Explorer Liver Passive Tracking
Liver surgery
-Standard of care
Liver abalation
-Standard of care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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William C Chapman, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Rosen CB. Management of Hepatic Metastases. Cancer Control. 1998 May;5(3 Suppl 1):30-31. doi: 10.1177/107327489800503S11. No abstract available.
Sardi A, Akbarov A, Conaway G. Management of primary and metastatic tumors to the liver. Oncology (Williston Park). 1996 Jun;10(6):911-25; discussion 926, 929-30.
Dick EA, Taylor-Robinson SD, Thomas HC, Gedroyc WM. Ablative therapy for liver tumours. Gut. 2002 May;50(5):733-9. doi: 10.1136/gut.50.5.733.
Parikh AA, Curley SA, Fornage BD, Ellis LM. Radiofrequency ablation of hepatic metastases. Semin Oncol. 2002 Apr;29(2):168-82. doi: 10.1053/sonc.2002.31673.
Arun KS, Huang TS, Blostein SD. Least-squares fitting of two 3-d point sets. IEEE Trans Pattern Anal Mach Intell. 1987 May;9(5):698-700. doi: 10.1109/tpami.1987.4767965.
Horn BKP.closed-form solution of absolute orientation using unit quaternions 4:629-642,1987
Besl PM,McKay ND.A method for registraion of 3-D shapes.IEEE Transaactions on Pattern Analysis and Machine Intelligence 14:239-256,1992
Cash DM,Siha Tk,Chapman,WC.Fast, accurate surface acquistion using a laser range scanner for image-guided surgical system.SPIE Medical Imaging,2002
Stefansic JD, Bass WA, Hartmann SL, Beasley RA, Sinha TK, Cash DM, Herline AJ, Galloway RL Jr. Design and implementation of a PC-based image-guided surgical system. Comput Methods Programs Biomed. 2002 Nov;69(3):211-24. doi: 10.1016/s0169-2607(01)00192-4.
Herline AJ, Stefansic JD, Debelak JP, Hartmann SL, Pinson CW, Galloway RL, Chapman WC. Image-guided surgery: preliminary feasibility studies of frameless stereotactic liver surgery. Arch Surg. 1999 Jun;134(6):644-9; discussion 649-50. doi: 10.1001/archsurg.134.6.644.
Herline AJ, Herring JL, Stefansic JD, Chapman WC, Galloway RL Jr, Dawant BM. Surface registration for use in interactive, image-guided liver surgery. Comput Aided Surg. 2000;5(1):11-7. doi: 10.1002/(SICI)1097-0150(2000)5:13.0.CO;2-G.
Pan S,Dawant BM.Automatic 3-D segmentation of the liver from abdominal CT images: a level-set approach. Proceedings of SPIE 4322:128-138,2001.
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201104308
Identifier Type: -
Identifier Source: org_study_id
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