Hepatocellular Cancer
Conditions
Keywords
Image Guided Liver Surgery
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.
Interventions
DEVICEExplorer Liver Image Guided System
DEVICEExplorer Liver Passive Tracking
PROCEDURELiver surgery
-Standard of care
PROCEDURELiver abalation
-Standard of care
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study) | 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. |
| 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) | 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 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) | Completion of surgery | -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) | 6 months post-ablation | -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. |
Countries
United States
Participant flow
Recruitment details
The study opened to participant enrollment on 10/24/2002 with the first participant enrolled on 12/27/2002 and the final participant was enrolled on 05/25/2011.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 19 |
| 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. | 0 |
| 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. | 0 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Determined to be ineligible | 0 | 10 | 0 | 0 |
Baseline characteristics
| Characteristic | Phase 1:Localize Anatomical Points on Liver Surface | Phase 2: Ceramic Bead | Total |
|---|---|---|---|
| Age, Continuous | 60 years | 58 years | 59 years |
| Region of Enrollment United States | 21 participants | 19 participants | 40 participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 20 Participants |
| Sex: Female, Male Male | 15 Participants | 5 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 19 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: Completion of surgery
Population: 10 patients were excluded as they were determined to be ineligible after enrollment but prior to surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1:Localize Anatomical Points on Liver Surface | 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) | Case 1 | 17.3 mm |
| Phase 1:Localize Anatomical Points on Liver Surface | 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) | Case 2 | 16.6 mm |
| Phase 1:Localize Anatomical Points on Liver Surface | 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) | Case 3 | 4.6 mm |
| Phase 1:Localize Anatomical Points on Liver Surface | 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) | Case 4 | 15.9 mm |
| Phase 1:Localize Anatomical Points on Liver Surface | 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) | Case 5 | 8.8 mm |
| Phase 1:Localize Anatomical Points on Liver Surface | 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) | Case 6 | 10.9 mm |
| Phase 1:Localize Anatomical Points on Liver Surface | 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) | Case 7 | 4.7 mm |
| Phase 1:Localize Anatomical Points on Liver Surface | 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) | Case 9 | 25.6 mm |
| Phase 1:Localize Anatomical Points on Liver Surface | 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) | Case 8 | 13.0 mm |
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.
Time frame: Completion of surgery
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1:Localize Anatomical Points on Liver Surface | Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study) | 18 participants |
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.
Time frame: Completion of surgery
Population: 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.
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.
Time frame: 6 months post-ablation
Population: 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.