NCT00878215

Clinical Application of Image-Guided Liver Surgery

Terminated Phase 2 Results posted Last updated 13 February 2018

What this trial tests

Phase 2 trial testing Explorer Liver Image Guided System in Hepatocellular Cancer in 40 participants. Terminated before completion.

Timeline

24 October 2002

Primary endpoint
25 May 2011

25 May 2011

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	24 October 2002
Primary completion	25 May 2011
Estimated completion	25 May 2011
Sites	1 location across United States

Drugs / interventions tested

• Explorer Liver Image Guided System
• Explorer Liver Passive Tracking
• Liver surgery
• Liver abalation

Conditions studied

• Hepatocellular Cancer — all drugs for Hepatocellular Cancer →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Hepatocellular Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study) Primary · Completion of 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.

Group	Value	95% CI
Phase 1:Localize Anatomical Points on Liver Surface	18

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) Primary · Completion of surgery

* 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 t

Case 1

Group	Value	95% CI
Phase 2: Ceramic Bead	17.3

Case 2

Group	Value	95% CI
Phase 2: Ceramic Bead	16.6

Case 3

Group	Value	95% CI
Phase 2: Ceramic Bead	4.6

Case 4

Group	Value	95% CI
Phase 2: Ceramic Bead	15.9

Case 5

Group	Value	95% CI
Phase 2: Ceramic Bead	8.8

Case 6

Group	Value	95% CI
Phase 2: Ceramic Bead	10.9

Case 7

Group	Value	95% CI
Phase 2: Ceramic Bead	4.7

Case 8

Group	Value	95% CI
Phase 2: Ceramic Bead	13.0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.