Clinical Application of Image-Guided Liver Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Explorer Liver Image Guided System (Device)
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.
干预措施: Explorer Liver Passive Tracking (Device)
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.
干预措施: Liver surgery (Procedure)
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.
干预措施: Explorer Liver Image Guided System (Device)
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.
干预措施: Explorer Liver Passive Tracking (Device)
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.
干预措施: Liver surgery (Procedure)
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.
干预措施: Explorer Liver Image Guided System (Device)
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.
干预措施: Explorer Liver Passive Tracking (Device)
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.
干预措施: Liver surgery (Procedure)
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.
干预措施: Liver abalation (Procedure)
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.
干预措施: Explorer Liver Image Guided System (Device)
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.
干预措施: Explorer Liver Passive Tracking (Device)
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.
干预措施: Liver abalation (Procedure)
结局指标
主要结局
Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点