A Comparison of Methods for Assisting Needle Angle Selection During Image-Guided Tissue Biopsy
- Currently, standard/conventional CT-guided biopsies proceed as follows - the physician:
1. obtains a pre-procedural CT scan,
2. plans the needle's angle based on this CT scan,
3. selects the angle at which the needle should be inserted based on the
pre-procedural CT scan,
4. inserts the needle while aiming to replicate that planned needle angle by using
only their visual-spatial abilities, and
5. re-images the patient to confirm needle location followed by needle
repositioning, if needed.
- Improving upon these standard methods of needle placement could have
widespread benefits (e.g. improved diagnostic tissue sampling, decreased
needle repositionings, etc.)
- To compare the angle difference between L-NASS (Method A) and the standard method
- To compare the angle difference between B-NASS (Method B) and the standard method
- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
- Must be undergoing a scheduled CT-guided biopsy.
- Must have ability to follow breathing instructions like holding breath (if
procedure is to be performed without general anesthesia).
- No serious concurrent medical illness that would preclude the patient from making a
rational informed decision on participation.
- Any known allergy to plastics or polymers (since the Ultem(Registered Trademark)
polymer could theoretically induce a rash in these patients, even though it is
- Pacemakers or automatic implantable cardiac defibrillators.
- Gross body weight above the CT table limit (450 pounds).
- Primary outcome measure for the first arm is:
--The difference between planned and achieved needle angle of a laser-assisted needle
angle selection system with the standard method (clinician's intuition) of CT-guided
- Primary outcome measure for the second arm is:
--The difference between planned and achieved needle angle of a block with pre-drilled
needle angles with the standard method (clinician's intuition).
- The tool for measuring the needle angles will be an FDA-approved electromagnetic
tracking system, which tracks needle movement and position.
- These comparisons will be done as a bystander study.
- Needle guidance system will only be used initially to select the angle during a
superficial, shallow needle insertion at the skin surface (less than 1 cm deep).
- At no time will the needle enter tissue that it wouldn't have otherwise entered as
neither system will be used to perform the biopsies at this time.
- The key portions of the procedure will not be altered in any substantive way.
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label
The angle error (the difference between the planned needle angle and the actual needle angle recorded prior to biopsy procedure).
Bradford Wood, M.D.
National Institutes of Health Clinical Center (CC)
United States: Federal Government
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