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| ID | Type | Description | Link |
|---|---|---|---|
| 110082 | Other Identifier | NIH Clinical Center |
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Investigator left NIH
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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:
PR(SqrRoot) 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 AIMS/OBJECTIVES
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):
METHODS/METHODOLOGY
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 biopsies/ablations 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:
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 i.e. lung, kidney, liver and other abdomen. If the patients are participating in a trial requiring paired procedures (i.e. 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:
If a patient has a lesion that is only visible on PET-CT/MR, or demonstrates heterogenous PET-CT/MR uptake, there will be a separate cohort of PET-CT/MR 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:
Subjects are excluded if:
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-CT/MR 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cone Beam CT | Other | Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation |
|
| Conventional CT | Other | Procedure performed with Conventional Computed Tomography (CT) image guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cone-beam computed tomography (CT) | Device | Imaging |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the Accuracy of Final Device Tip Position | To compare the accuracy of the biopsy needle between the software guidance and conventional CT. The accuracy of the needle position was calculated in millimeters by using the difference between the x,y,z coordinates of the tip of the actual needle before specimen collection. Actual and planned needle paths were compared using coordinates and measured in millimeters. | 1 hour |
| Accuracy of Final Device Path (Vector) | Comparing the accuracy of the path the biopsy needle took to get to the site | 1 hour |
| Radiation Doses Between Xperguide and Conventional CT | Comparing radiation doses to determine if there is a change in the dose between the two interventions | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the Number of Repositioning Maneuvers | To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy. | 1 hour |
| Rates of Definitive Pathologic Diagnosis |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Bradford Wood, M.D. | National Institutes of Health Clinical Center (CC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20352357 | Background | Carrafiello G, Mangini M, De Bernardi I, Fontana F, Dionigi G, Cuffari S, Imperatori A, Lagana D, Fugazzola C. Microwave ablation therapy for treating primary and secondary lung tumours: technical note. Radiol Med. 2010 Sep;115(6):962-74. doi: 10.1007/s11547-010-0547-7. Epub 2010 Mar 29. English, Italian. | |
| 18029850 | Background |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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The PILOT Arm of the study was done prior to enrolling participants in the main phase of the study. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures. Participants enrolled in the PILOT Arm were not randomized to either the Cone Beam CT or Conventional CT Arms and not included in the analysis.
Recruitment period = 2/4/2011 - 5/15/2014 Recruitment location = Interventional Radiology Clinic, Department of Radiology and Imaging Sciences, Clinical Center, NIH
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| ID | Title | Description |
|---|---|---|
| FG000 | Cone Beam CT | Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation |
| FG001 | Conventional CT | Procedure performed with Conventional Computed Tomography (CT) image guidance |
| FG002 | PILOT | Procedures performed with Xperguide without randomization to familiarize operators. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cone Beam CT | Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation |
| BG001 | Conventional CT | Procedure performed with Conventional Computed Tomography (CT) image guidance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparing the Accuracy of Final Device Tip Position | To compare the accuracy of the biopsy needle between the software guidance and conventional CT. The accuracy of the needle position was calculated in millimeters by using the difference between the x,y,z coordinates of the tip of the actual needle before specimen collection. Actual and planned needle paths were compared using coordinates and measured in millimeters. | Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures. | Posted | Mean | Standard Deviation | mm | 1 hour |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cone Beam CT | Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Grade 3. Possibly related to research (procedure). Patient was hospitalized for 3 days for a small left apical pneumothorax increased since immediate post lung biopsy verified by chest CT. A chest tube had to be placed in IR after the biopsy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradford Wood, MD | National Institutes of Health | (301) 496-7739 | bwood@nih.gov |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D009369 | Neoplasms |
| D004653 | Empyema |
| D006099 | Granuloma |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054893 | Cone-Beam Computed Tomography |
| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D014056 | Tomography, X-Ray |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| Conventional Computed Tomography (CT) | Device | Imaging |
|
|
Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.
| 1 hour |
| Racadio JM, Babic D, Homan R, Rampton JW, Patel MN, Racadio JM, Johnson ND. Live 3D guidance in the interventional radiology suite. AJR Am J Roentgenol. 2007 Dec;189(6):W357-64. doi: 10.2214/AJR.07.2469. |
| 20033329 | Background | Spelle L, Ruijters D, Babic D, Homan R, Mielekamp P, Guillermic J, Moret J. First clinical experience in applying XperGuide in embolization of jugular paragangliomas by direct intratumoral puncture. Int J Comput Assist Radiol Surg. 2009 Nov;4(6):527-33. doi: 10.1007/s11548-009-0370-6. Epub 2009 Jun 13. |
| 27461586 | Result | Abi-Jaoudeh N, Fisher T, Jacobus J, Skopec M, Radaelli A, Van Der Bom IM, Wesley R, Wood BJ. Prospective Randomized Trial for Image-Guided Biopsy Using Cone-Beam CT Navigation Compared with Conventional CT. J Vasc Interv Radiol. 2016 Sep;27(9):1342-1349. doi: 10.1016/j.jvir.2016.05.034. Epub 2016 Jul 25. |
| BG002 | PILOT | Procedures performed with Xperguide without randomization to familiarize operators. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Conventional CT |
Procedure performed with Conventional Computed Tomography (CT) image guidance |
|
|
|
| Primary | Accuracy of Final Device Path (Vector) | Comparing the accuracy of the path the biopsy needle took to get to the site | Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures. | Posted | Mean | Standard Deviation | mm | 1 hour |
|
|
|
|
| Primary | Radiation Doses Between Xperguide and Conventional CT | Comparing radiation doses to determine if there is a change in the dose between the two interventions | Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures. | Posted | Mean | Standard Deviation | mGy | 1 hour |
|
|
|
|
| Secondary | Compare the Number of Repositioning Maneuvers | To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy. | Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures. | Posted | Mean | Standard Deviation | number of repositioning maneuvers | 1 hour |
|
|
|
|
| Secondary | Rates of Definitive Pathologic Diagnosis | Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up. | Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures. | Posted | Number | percent of accuracy | 1 hour |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Conventional CT | Procedure performed with Conventional Computed Tomography (CT) image guidance | 0 | 29 | 1 | 29 | 0 | 29 |
| EG002 | Pilot Arm | Pilot participants were enrolled to familiarize operators with performing Xperguide procedures. | 0 | 21 | 0 | 21 | 0 | 21 |
|
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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |