Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy

Study Overview
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Brief Summary
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This study investigates whether a new image fusion technology can reduce patient radiation dose from CTs and/or procedure time during biopsies of lung, liver or kidney.

Detailed Description
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This study proposes the use of a new fusion technology, Scenergy (Clear Guide Medical; FDA 510(k) K171677), which fuses CT images to real-time US images to minimize the drawbacks of each modality while enhancing their benefits. Such benefits include, the reduction of radiation dose to the patient with the fusion of initial CT imaging overlaying the live US images. The fused imaging software allows the operator to watch the needle tip advance towards the lesion on both live US and overlaid CT imaging. In such a setting, the operator would only need to perform an initial CT scan, advance the needle into position using fused US/CT images, and a final CT scan to ensure needle tip location. This eliminates interval CT scans that are usually required after each incremental needle position adjustment, and thus, reduces radiation dose to the patient and wasted procedural time during the incremental CT scans.

Official Title
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Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy

Conditions
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Liver Biopsy, Lung Biopsy, Kidney Biopsy

Intervention / Treatment
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* Device: SCENERGY-guided Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients between the ages of 18 and 80 years old at time of procedure who are pre-scheduled for a lung, kidney, or liver biopsy. Exclusion Criteria: any patient who was under the age of 18 or over the age of 80 at time of the procedure or who does not wish to volunteer for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: testing whether biopsies and ablations performed with the SCENERGY result in less patient radiation dose or reduced procedure time compared to biopsies performed under CT-guidance only.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CT-only guided biopsy<br>The current standard of care for biopsy at Temple University Hospital. | |
| Experimental: SCENERGY-guided Biopsy<br>The use of the SCENERGY to fuse CT and Ultrasound for biopsy | Device: SCENERGY-guided Biopsy<br>* Use of SCENERGY during a lung, liver or kidney biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Dose during Procedure | The number of CTs or Fluoroscopy shots during the biopsy | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Target of Biopsy | The amount of time in seconds that the physician takes to reach the target of biopsy | 1 hour | 
| Experience Level | Number of years physician has practiced in Interventional Radiology | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung biopsy, kidney biopsy, liver biopsy, image fusion