Trial Outcomes & Findings for Clinical Application of Image-Guided Liver Surgery (NCT NCT00878215)

Results Overview

* 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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Completion of surgery

Results posted on

2018-02-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	21	19
Overall Study COMPLETED	21	9
Overall Study NOT COMPLETED	0	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Overall Study Determined to be ineligible	0	10	0	0

Baseline Characteristics

Clinical Application of Image-Guided Liver Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1:Localize Anatomical Points on Liver Surface n=21 Participants -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.	Phase 2: Ceramic Bead n=19 Participants -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.	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.	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.	Total n=40 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	58 years n=7 Participants	—	—	59 years n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	14 Participants n=7 Participants	—	—	20 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	5 Participants n=7 Participants	—	—	20 Participants n=21 Participants
Region of Enrollment United States	21 participants n=5 Participants	19 participants n=7 Participants	—	—	40 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

* 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.

Outcome measures

Outcome measures
Measure	Phase 1:Localize Anatomical Points on Liver Surface n=19 Participants -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.
Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study)	18 participants

PRIMARY outcome

Timeframe: Completion of surgery

Population: 10 patients were excluded as they were determined to be ineligible after enrollment but prior to 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

Outcome measures

Outcome measures
Measure	Phase 1:Localize Anatomical Points on Liver Surface n=9 Participants -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.
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
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
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
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
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
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
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
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
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

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

-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.

Outcome measures

Outcome data not reported

Adverse Events

Phase 1:Localize Anatomical Points on Liver Surface

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 2: Ceramic Bead

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 3: Ablative Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 4: Ablative Therapy (Not Liver Resection Candidates)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William C. Chapman, M.D.

Washington University School of Medicine

Phone: 314-362-7792

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place