Kidney Biopsy, Liver Biopsy, Lung Biopsy
Conditions
Keywords
lung biopsy, kidney biopsy, liver biopsy, image fusion
Brief summary
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
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.
Interventions
DEVICESCENERGY-guided Biopsy
Use of SCENERGY during a lung, liver or kidney biopsy
Sponsors
Temple University
National Institutes of Health (NIH)
Clear Guide Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking is impossible due to the hardware that is present when using the SCENERGY
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dose during Procedure | 1 hour | The number of CTs or Fluoroscopy shots during the biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Target of Biopsy | 1 hour | The amount of time in seconds that the physician takes to reach the target of biopsy |
| Experience Level | 1 hour | Number of years physician has practiced in Interventional Radiology |
Countries
United States
Outcome results
None listed