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Liver Extracts

-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.

Explorer Liver Image Guided System

Explorer Liver Passive Tracking

Liver surgery

Liver abalation

William C Chapman, MD

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.

Clinical Application of Image-Guided Liver Surgery

* 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.

* 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

-A measurement of the ablation probe placement via the burn zone will be performed by pathology via specimen sectioning.

-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.

Washington University School of Medicine

Phase 1:Localize Anatomical Points on Liver Surface

Phase 2: Ceramic Bead

Phase 3: Ablative Therapy

Phase 4: Ablative Therapy (Not Liver Resection Candidates)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

William C. Chapman, M.D.

2 patients were excluded due to the fact that liver surface data was not acquired for these cases due to equipment malfunctions and not due to a failure in the guidance method in general.

Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study)

Case 1

Case 2

Case 3

Case 4

Case 5

Case 6

Case 7

Case 8

Case 9

10 patients were excluded as they were determined to be ineligible after enrollment but prior to surgery.

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)

The study closed early as the imaging-guidance system became commercially available as the Explorer Liver Image Guided System and the Explorer Liver Passive Tracking device.

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)

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)

Spots Global Cancer Trial Database for explorer liver image guided system