Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01287013
Status:
TERMINATED
Last Update Posted:
2018-01-05
First Post:
2011-01-25
Brief Title:
Comparing Xperguide vs Conventional Methods During Percutaneous Image Guided Procedures
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prospective Randomized Trial Comparing Navigation With Xperguide vs Conventional Methods During Percutaneous Image Guided Procedures
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator left NIH
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography CT scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue Xperguide and electromagnetic EM tracking are two new procedures being studied to help guide the needle Xperguide is software that uses CT images to help the doctor choose the needle path EM tracking uses special medical tools with miniature coils that act like a Global Positioning Satellite GPS device to show the location of the needle in the body Xperguide and EM tracking have been used in humans and have good results but they have not been compared with each other and regular CT to determine whether they are better than the standard approach
Objectives
- To compare the results of Xperguide electromagnetic tracking and regular computed tomography during a guided percutaneous procedure
Eligibility
- Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure
Design
Participants will be screened with a physical examination and medical history and the results of any previous imaging studies will be examined before study enrollment
After a pilot phase the study will involve two phases to compare the results of the different procedures The first phase will involve comparing Xperguide to CT and the second will involve comparing Xperguide to EM tracking
Phase 1 participants will be assigned to one of two procedure groups Group 1 will have Xperguide and Group 2 will have regular CT Participants who are scheduled to have repeated procedures like a biopsy before and after chemotherapy will be randomized for the first procedure and the second procedure will be done using the other method
Phase 2 participants will be assigned to one of two procedure groups Group 1 will have Xperguide and Group 2 will have EM tracking Participants who are scheduled to have repeated procedures like a biopsy before and after chemotherapy will be randomized for the first procedure and the second procedure will be done using the other method
Standard post-procedure followup care will be given after the study procedure is completed
- Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography CT scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue Xperguide and electromagnetic EM tracking are two new procedures being studied to help guide the needle Xperguide is software that uses CT images to help the doctor choose the needle path EM tracking uses special medical tools with miniature coils that act like a Global Positioning Satellite GPS device to show the location of the needle in the body Xperguide and EM tracking have been used in humans and have good results but they have not been compared with each other and regular CT to determine whether they are better than the standard approach
Objectives
- To compare the results of Xperguide electromagnetic tracking and regular computed tomography during a guided percutaneous procedure
Eligibility
- Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure
Design
Participants will be screened with a physical examination and medical history and the results of any previous imaging studies will be examined before study enrollment
After a pilot phase the study will involve two phases to compare the results of the different procedures The first phase will involve comparing Xperguide to CT and the second will involve comparing Xperguide to EM tracking
Phase 1 participants will be assigned to one of two procedure groups Group 1 will have Xperguide and Group 2 will have regular CT Participants who are scheduled to have repeated procedures like a biopsy before and after chemotherapy will be randomized for the first procedure and the second procedure will be done using the other method
Phase 2 participants will be assigned to one of two procedure groups Group 1 will have Xperguide and Group 2 will have EM tracking Participants who are scheduled to have repeated procedures like a biopsy before and after chemotherapy will be randomized for the first procedure and the second procedure will be done using the other method
Standard post-procedure followup care will be given after the study procedure is completed
Detailed Description:
PRSqrRoot CIS
This is a phase II prospective randomized trial comparing a novel navigation method Xperguide to conventional CT and electromagnetic tracking EM during percutaneous image guided procedures Xperguide is a navigation tool that utilizes a cone beam CT CBCT obtained in the angiography suite overlaid on fluoroscopy for needle guidance during image guided procedures The needle entry point and path are planned on the CBCT and the determined path is overlaid on fluoroscopy image for real time guidance
SPECIFIC AIMSOBJECTIVES
1 The primary aims are
a Pilot trial
i To familiarize operators with outcome measures allowing for fair comparison in the subsequent study
b Main trial will have 2 phases with similar outcomes criteria and aims below
i comparing Xperguide to conventional imaging superiority design
ii comparing Xperguide to EM tracking equivalence design
1 To compare the accuracy of final device tip position and path vector
2 To compare the number of repositioning maneuvers
3 To compare the radiation dose
4 To compare rates of definitive pathological diagnosis and response rate per EASL criteria for ablations
METHODSMETHODOLOGY
For non-vascular image guided interventions patients undergoing biopsies and ablations procedures requiring CT guidance are eligible for inclusion and randomization An initial pilot study will be done in which each operator will perform at least 5 cases using Xperguide completing the case report forms This will ensure experience with outcome measures and fair comparison in the subsequent study Once one of the operators reaches the minimal required cases the main trial will begin for that operator However every other operator must each complete the minimal number of cases with the case report forms to enroll patients in the main trial Initially we will compare Xperguide with conventional CT with several cohorts of patients mainly lung biopsies and ablations kidney biopsiesablations and other abdominal biopsies ablations In ablations of large lesions Xperguide composite ablation software can provide input on the expected ablation zones Each probe will be positioned in the same manner as any biopsy needle following steps described in section 4 If this specific composite ablation module of the
software is not commercially released and FDA cleared at the time of the study then this software will only be used on protocol to help the physician determine ideal needle positioning for complete ablation Once consent is obtained the participant is randomized to either conventional imaging or Xperguide In addition if it is known that the patient is participating in a trial which requires a repeat paired pre and post treatment procedure of the same site then the randomization will determine which modality is used for guidance at the first visit and the other modality will automatically be used for the second procedure In these cases if the patient gives consent they will be randomized to one of two categories
1 Xperguide for the initial procedure and conventional CT for the 2nd procedure
2 Conventional CT for the initial procedure and Xperguide for the 2nd procedure
Then in the second phase of the trial Xperguide will be compared to EM tracking for biopsies and ablations requiring CT guidance in an equivalence study Once consent is obtained the participant will be randomized into EM tracking or Xperguide The patients would be divided into different cohorts depending on the anatomic site of the interventions ie lung kidney liver and other abdomen If the patients are participating in a trial requiring paired procedures ie pre and post treatment the randomization will determine which modality is used for the initial procedure and the other modality will be used for the second procedure In summary there will be two potential categories
1 EM tracking for the initial procedure and Xperguide for the 2nd procedure
2 Xperguide for the initial procedure and EM tracking for the 2nd procedure
If a patient has a lesion that is only visible on PET-CTMR or demonstrates heterogenous PET-CTMR uptake there will be a separate cohort of PET-CTMR guided biopsies and ablations using Xperguide vs EM tracking There is also the need for a cohort for ablations with complimentary use of ultrasound at the discretion of the operator in order to conform to our standard of care at the NIH
ELIGIBILITY
Subjects are eligible if
1 they are over 18 years of age
2 they are scheduled for image guided procedure
3 the lesion is not superficial deeper than 3cm
Subjects are excluded if
1 they have an altered mental status that precludes understanding or consenting for the procedure
2 they are unable to hold reasonably still on a procedure table for the length of the procedure
3 they are unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
4 their gross body weight is over 375 pounds which the upper limit of the CT and
angiography tables
REQUIRED SAMPLE SIZE
A pilot study will be performed to ensure operator experience with Xperguide and EM tracking for fair comparison In the pilot study each operator must perform 5 cases with Xperguide completing the case report forms There are 5 potential operators therefore a maximum of 25 patients if all 5 operators participate to the fullest
The first phase of the main trial comparing Xperguide with conventional CT was powered for sample size with a standard superiority design aimed to statistically establish that Xperguide is better than conventional CT defined as requiring fewer needle repositioning efforts These calculations yield a total sample size of 60 patients with 20 patients per anatomical site
For the second phase of the trial comparing Xperguide to EM tracking a two sided equivalence design based on accuracy and number of needle repositioning was used for sample size considerations and yielded 192 patients Therefore 16 patients per modality per anatomical site will be randomized with two additional cohorts for PET-CTMR procedures and composite ablations
Number of Participants 277
Recruitment Time Frame 4 years
Number of sites 1
Type of Study prospective randomized clinical trial after an initial pilot period
This is a phase II prospective randomized trial comparing a novel navigation method Xperguide to conventional CT and electromagnetic tracking EM during percutaneous image guided procedures Xperguide is a navigation tool that utilizes a cone beam CT CBCT obtained in the angiography suite overlaid on fluoroscopy for needle guidance during image guided procedures The needle entry point and path are planned on the CBCT and the determined path is overlaid on fluoroscopy image for real time guidance
SPECIFIC AIMSOBJECTIVES
1 The primary aims are
a Pilot trial
i To familiarize operators with outcome measures allowing for fair comparison in the subsequent study
b Main trial will have 2 phases with similar outcomes criteria and aims below
i comparing Xperguide to conventional imaging superiority design
ii comparing Xperguide to EM tracking equivalence design
1 To compare the accuracy of final device tip position and path vector
2 To compare the number of repositioning maneuvers
3 To compare the radiation dose
4 To compare rates of definitive pathological diagnosis and response rate per EASL criteria for ablations
METHODSMETHODOLOGY
For non-vascular image guided interventions patients undergoing biopsies and ablations procedures requiring CT guidance are eligible for inclusion and randomization An initial pilot study will be done in which each operator will perform at least 5 cases using Xperguide completing the case report forms This will ensure experience with outcome measures and fair comparison in the subsequent study Once one of the operators reaches the minimal required cases the main trial will begin for that operator However every other operator must each complete the minimal number of cases with the case report forms to enroll patients in the main trial Initially we will compare Xperguide with conventional CT with several cohorts of patients mainly lung biopsies and ablations kidney biopsiesablations and other abdominal biopsies ablations In ablations of large lesions Xperguide composite ablation software can provide input on the expected ablation zones Each probe will be positioned in the same manner as any biopsy needle following steps described in section 4 If this specific composite ablation module of the
software is not commercially released and FDA cleared at the time of the study then this software will only be used on protocol to help the physician determine ideal needle positioning for complete ablation Once consent is obtained the participant is randomized to either conventional imaging or Xperguide In addition if it is known that the patient is participating in a trial which requires a repeat paired pre and post treatment procedure of the same site then the randomization will determine which modality is used for guidance at the first visit and the other modality will automatically be used for the second procedure In these cases if the patient gives consent they will be randomized to one of two categories
1 Xperguide for the initial procedure and conventional CT for the 2nd procedure
2 Conventional CT for the initial procedure and Xperguide for the 2nd procedure
Then in the second phase of the trial Xperguide will be compared to EM tracking for biopsies and ablations requiring CT guidance in an equivalence study Once consent is obtained the participant will be randomized into EM tracking or Xperguide The patients would be divided into different cohorts depending on the anatomic site of the interventions ie lung kidney liver and other abdomen If the patients are participating in a trial requiring paired procedures ie pre and post treatment the randomization will determine which modality is used for the initial procedure and the other modality will be used for the second procedure In summary there will be two potential categories
1 EM tracking for the initial procedure and Xperguide for the 2nd procedure
2 Xperguide for the initial procedure and EM tracking for the 2nd procedure
If a patient has a lesion that is only visible on PET-CTMR or demonstrates heterogenous PET-CTMR uptake there will be a separate cohort of PET-CTMR guided biopsies and ablations using Xperguide vs EM tracking There is also the need for a cohort for ablations with complimentary use of ultrasound at the discretion of the operator in order to conform to our standard of care at the NIH
ELIGIBILITY
Subjects are eligible if
1 they are over 18 years of age
2 they are scheduled for image guided procedure
3 the lesion is not superficial deeper than 3cm
Subjects are excluded if
1 they have an altered mental status that precludes understanding or consenting for the procedure
2 they are unable to hold reasonably still on a procedure table for the length of the procedure
3 they are unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
4 their gross body weight is over 375 pounds which the upper limit of the CT and
angiography tables
REQUIRED SAMPLE SIZE
A pilot study will be performed to ensure operator experience with Xperguide and EM tracking for fair comparison In the pilot study each operator must perform 5 cases with Xperguide completing the case report forms There are 5 potential operators therefore a maximum of 25 patients if all 5 operators participate to the fullest
The first phase of the main trial comparing Xperguide with conventional CT was powered for sample size with a standard superiority design aimed to statistically establish that Xperguide is better than conventional CT defined as requiring fewer needle repositioning efforts These calculations yield a total sample size of 60 patients with 20 patients per anatomical site
For the second phase of the trial comparing Xperguide to EM tracking a two sided equivalence design based on accuracy and number of needle repositioning was used for sample size considerations and yielded 192 patients Therefore 16 patients per modality per anatomical site will be randomized with two additional cohorts for PET-CTMR procedures and composite ablations
Number of Participants 277
Recruitment Time Frame 4 years
Number of sites 1
Type of Study prospective randomized clinical trial after an initial pilot period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 110082 | OTHER | NIH Clinical Center | None |