Trial Information

A Comparison of Methods for Assisting Needle Angle Selection During Image-Guided Tissue Biopsy

Background:

- 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.)

Objectives:

- To compare the angle difference between L-NASS (Method A) and the standard method
(clinician intuition)

- To compare the angle difference between B-NASS (Method B) and the standard method
(clinician intuition)

Eligibility:

- Ages Eligible for Study: 18 Years and older

- Genders Eligible for Study: Both

- Inclusion:

- 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).

- Exclusion:

- 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
hypoallergenic).

- Pacemakers or automatic implantable cardiac defibrillators.

- Gross body weight above the CT table limit (450 pounds).

Design:

- 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
biopsy.

- 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.