Clinical Application of Image-Guided Liver Surgery

Hepatocellular Cancer Clinical Trial

Official title:

Clinical Application of Image-Guided Liver Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00878215
• Other study ID #: 201104308
• Status: Terminated
• Phase: Phase 2
• First received: April 7, 2009
• Last updated: January 16, 2018
• Start date: October 24, 2002
• Est. completion date: May 25, 2011

Study information

• Verified date: January 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: May 25, 2011
• Est. primary completion date: May 25, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatocellular Cancer
• Liver Neoplasms

Intervention

Device:
• Explorer Liver Image Guided System

• Explorer Liver Passive Tracking

Procedure:
• Liver surgery
-Standard of care
• Liver abalation
-Standard of care

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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

Cash DM,Siha Tk,Chapman,WC.Fast, accurate surface acquistion using a laser range scanner for image-guided surgical system.SPIE Medical Imaging,2002

Dick EA, Taylor-Robinson SD, Thomas HC, Gedroyc WM. Ablative therapy for liver tumours. Gut. 2002 May;50(5):733-9. Review. — View 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. — View 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. — View Citation

Horn BKP.closed-form solution of absolute orientation using unit quaternions 4:629-642,1987

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.

Parikh AA, Curley SA, Fornage BD, Ellis LM. Radiofrequency ablation of hepatic metastases. Semin Oncol. 2002 Apr;29(2):168-82. Review. — View Citation

Rosen CB. Management of Hepatic Metastases. Cancer Control. 1998 May;5(3 Suppl 1):30-31. — View 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. Review. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Completion of surgery
Primary	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	Completion of surgery
Primary	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.	Completion of surgery
Primary	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.	6 months post-ablation

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine