An interventional study of Cone-beam computed tomography (CT) and Conventional Computed Tomography (CT) in Infection, Cancer and Neoplasm, sponsored by National Institutes of Health Clinical Center (CC). Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-01-05.
Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Diagnostic
Background:
Objectives:
Eligibility:
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
they are over 18 years of age
EXCLUSION CRITERIA:
Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation
Device: Cone-beam computed tomography (CT)
Procedure performed with Conventional Computed Tomography (CT) image guidance
Device: Conventional Computed Tomography (CT)
Imaging
Also known as: XperCT (Philips, Best), XperGuide CT
Imaging
Also known as: Conventional CT (Philips)
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.
Time frame: 1 hour
Accuracy of Final Device Path (Vector)
Comparing the accuracy of the path the biopsy needle took to get to the site
Time frame: 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
Time frame: 1 hour
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.
Time frame: 1 hour
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.
Time frame: 1 hour
Recruitment period = 2/4/2011 - 5/15/2014 Recruitment location = Interventional Radiology Clinic, Department of Radiology and Imaging Sciences, Clinical Center, NIH
| Milestone | Cone Beam CT | Conventional CT | PILOT |
|---|---|---|---|
| Started | 32 | 34 | 21 |
| Completed | 29 | 29 | 0 |
| Not completed | 3 | 5 | 21 |
| Withdrew: Non-evaluable | 3 | 5 | 21 |
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.
| mm | Cone Beam CT | Conventional CT |
|---|---|---|
| Comparing the Accuracy of Final Device Tip Position | 4.9 ± 4.1 | 12.2 ± 8.1 |
Comparing the accuracy of the path the biopsy needle took to get to the site
| mm | Cone Beam CT | Convetional CT |
|---|---|---|
| Accuracy of Final Device Path (Vector) | 8.8 ± 5.4 | 28.3 ± 20.5 |
Comparing radiation doses to determine if there is a change in the dose between the two interventions
| mGy | Cone Beam CT | Conventional CT |
|---|---|---|
| Radiation Doses Between Xperguide and Conventional CT | 53.3 ± 33.3 | 75.4 ± 62.6 |
To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.
| number of repositioning maneuvers | Cone Beam CT | Conventional CT |
|---|---|---|
| Compare the Number of Repositioning Maneuvers | 0.3 ± 0.5 | 1.9 ± 2.3 |
Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.
| percent of accuracy | Cone Beam CT | Conventional CT |
|---|---|---|
| Rates of Definitive Pathologic Diagnosis | 93.9 | 90.9 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cone Beam CT | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Conventional CT | 0/29 (0%) | 1/29 (3.4%) | 0/29 (0%) |
| Pilot Arm | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Event | Cone Beam CT | Conventional CT | Pilot Arm |
|---|---|---|---|
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/29 | 1/29 | 0/21 |
| Age, Categorical(Participants) | Cone Beam CT | Conventional CT | PILOT | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 1 | 1 |
| Between 18 and 65 years | 25 | 25 | 8 | 58 |
| >=65 years | 7 | 9 | 12 | 28 |
| Sex: Female, Male(Participants) | Cone Beam CT | Conventional CT | PILOT | Total |
|---|---|---|---|---|
| Female | 18 | 8 | 4 | 30 |
| Male | 14 | 26 | 17 | 57 |
Plan to share: No
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National Institutes of Health Clinical Center (CC)