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Clinical Application of Image-Guided Liver Surgery

Primary Purpose

Hepatocellular Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Explorer Liver Image Guided System
Explorer Liver Passive Tracking
Liver surgery
Liver abalation
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Cancer focused on measuring Image Guided Liver Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1:Localize Anatomical Points on Liver Surface

Phase 2: Ceramic bead

Phase 3: Ablative therapy

Phase 4: Ablative therapy (not liver resection candidates)

Arm Description

-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.

-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.

-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.

-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.

Outcomes

Primary Outcome Measures

Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study)
10 successful intraoperative registrations with no more than 30% failure rate over all the cases will be considered a successful endpoint A successful registration is defined as one which yields an RMS surface residual of ≤ 10 mm and is determined to be success after qualitative evaluation.
Accuracy With Which Image-guided Surgery (IGS) Can be Used to Implant a Ceramic Bead Inside a Tumor as Measured by Successful Deliveries of the Bead to Within 8mm of the Pre-operatively Planned Target Point (Phase 2 Portion of Study)
Calculation of bead delivery accuracy using the IGS system involves the acquisition of images of the resected specimen and then the co-registration of the post-resection images to the pre-operative image set. Given that the target location is marked in the pre-operative image set and the registration calculation allows an overlay of the two image sets a Euclidean distance error can be calculated between the true bead location and the pre-operatively determined target. Given that the error involved in computing the registration between the two image sets is included within the bead delivery target error calculation it is imperative that the impact of registration error is minimized. Numbers represented are the distance between the planned target site and the true bead location
Target Accuracy of an Ablation Probe Using Image-guided Surgery Technology as Measured by the Number of Participants Who Had Ablation Burns Within a 5mm Radius of the Tumor Centroid (Phase 3 Portion of Study)
-A measurement of the ablation probe placement via the burn zone will be performed by pathology via specimen sectioning.
The Number of Participants Who Have Complete Ablation According to Early Post-ablative Imaging Studies as Well as no Recurrence of the Tumor Within 6 Months (Phase 4 Portion of the Study)
-A successful endpoint will be 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.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2009
Last Updated
January 16, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00878215
Brief Title
Clinical Application of Image-Guided Liver Surgery
Official Title
Clinical Application of Image-Guided Liver Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
The image-guidance system became commercially available
Study Start Date
October 24, 2002 (Actual)
Primary Completion Date
May 25, 2011 (Actual)
Study Completion Date
May 25, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Cancer
Keywords
Image Guided Liver Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1:Localize Anatomical Points on Liver Surface
Arm Type
Experimental
Arm Description
-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.
Arm Title
Phase 2: Ceramic bead
Arm Type
Experimental
Arm Description
-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.
Arm Title
Phase 3: Ablative therapy
Arm Type
Experimental
Arm Description
-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.
Arm Title
Phase 4: Ablative therapy (not liver resection candidates)
Arm Type
Experimental
Arm Description
-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.
Intervention Type
Device
Intervention Name(s)
Explorer Liver Image Guided System
Intervention Type
Device
Intervention Name(s)
Explorer Liver Passive Tracking
Intervention Type
Procedure
Intervention Name(s)
Liver surgery
Intervention Description
-Standard of care
Intervention Type
Procedure
Intervention Name(s)
Liver abalation
Intervention Description
-Standard of care
Primary Outcome Measure Information:
Title
Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study)
Description
10 successful intraoperative registrations with no more than 30% failure rate over all the cases will be considered a successful endpoint A successful registration is defined as one which yields an RMS surface residual of ≤ 10 mm and is determined to be success after qualitative evaluation.
Time Frame
Completion of surgery
Title
Accuracy With Which Image-guided Surgery (IGS) Can be Used to Implant a Ceramic Bead Inside a Tumor as Measured by Successful Deliveries of the Bead to Within 8mm of the Pre-operatively Planned Target Point (Phase 2 Portion of Study)
Description
Calculation of bead delivery accuracy using the IGS system involves the acquisition of images of the resected specimen and then the co-registration of the post-resection images to the pre-operative image set. Given that the target location is marked in the pre-operative image set and the registration calculation allows an overlay of the two image sets a Euclidean distance error can be calculated between the true bead location and the pre-operatively determined target. Given that the error involved in computing the registration between the two image sets is included within the bead delivery target error calculation it is imperative that the impact of registration error is minimized. Numbers represented are the distance between the planned target site and the true bead location
Time Frame
Completion of surgery
Title
Target Accuracy of an Ablation Probe Using Image-guided Surgery Technology as Measured by the Number of Participants Who Had Ablation Burns Within a 5mm Radius of the Tumor Centroid (Phase 3 Portion of Study)
Description
-A measurement of the ablation probe placement via the burn zone will be performed by pathology via specimen sectioning.
Time Frame
Completion of surgery
Title
The Number of Participants Who Have Complete Ablation According to Early Post-ablative Imaging Studies as Well as no Recurrence of the Tumor Within 6 Months (Phase 4 Portion of the Study)
Description
-A successful endpoint will be 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.
Time Frame
6 months post-ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C Chapman, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10762479
Citation
Rosen CB. Management of Hepatic Metastases. Cancer Control. 1998 May;5(3 Suppl 1):30-31. doi: 10.1177/107327489800503S11. No abstract available.
Results Reference
background
PubMed Identifier
8823803
Citation
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.
Results Reference
background
PubMed Identifier
11950826
Citation
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.
Results Reference
background
PubMed Identifier
11951215
Citation
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.
Results Reference
background
PubMed Identifier
21869429
Citation
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.
Results Reference
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Citation
Horn BKP.closed-form solution of absolute orientation using unit quaternions 4:629-642,1987
Results Reference
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Citation
Besl PM,McKay ND.A method for registraion of 3-D shapes.IEEE Transaactions on Pattern Analysis and Machine Intelligence 14:239-256,1992
Results Reference
background
Citation
Cash DM,Siha Tk,Chapman,WC.Fast, accurate surface acquistion using a laser range scanner for image-guided surgical system.SPIE Medical Imaging,2002
Results Reference
background
PubMed Identifier
12204449
Citation
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.
Results Reference
background
PubMed Identifier
10367875
Citation
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.
Results Reference
background
PubMed Identifier
10767091
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Clinical Application of Image-Guided Liver Surgery

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