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

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT01218854

Collaborator

(none)

Enrollment

Location

Arms

55.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Currently, standard procedures for biopsies that are guided by computed tomography (CT) imaging involve CT scans and a computer program to plan and illustrate where the physician will place the needle to obtain the required cells or tissue. Inserting the biopsy needle at the planned angle is not an easy task, because the appropriate angle of insertion must be estimated based on prior experience. Researchers are studying experimental techniques that might provide better guidance about the right angle to insert the biopsy needle and thereby improve the collection of the appropriate biopsy cells or tissue.

Objectives:

To evaluate the effectiveness of two biopsy needle guidance methods in CT-guided tissue biopsy.

Eligibility:

Individuals at least 18 years of age who are scheduled to have CT-guided tissue biopsy.

Design:

Participants will have a tissue biopsy guided by CT scans and either a laser system or a plastic block to illustrate the appropriate angle of insertion. The skin will be numbed with anesthetic to minimize discomfort during the procedure.
Before inserting the biopsy needle, the study physician will hold the needle in place so that a Food and Drug Administration-approved medical GPS (electromagnetic tracking) system can measure the needle angle as it enters the tissue.
After the needle angle data has been collected, researchers will proceed with the actual biopsy procedure as it would normally occur, using standard methods.
No additional treatment will be provided as part of this protocol.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms Liver Neoplasms Kidney Neoplasms Cancer	Device: Needle angle measurement	Phase 1

Detailed Description

Background:

Currently, standard/conventional CT-guided biopsies proceed as follows the physician:

obtains a pre-procedural CT scan,
plans the needle s angle based on this CT scan,
selects the angle at which the needle should be inserted based on the pre-procedural CT scan,
inserts the needle while aiming to replicate that planned needle angle by using only their visual-spatial abilities, and
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.) We will be studying three needle angle selection systems. The laser-assisted needle angle selection system or LNASS, is a custom fabricated device that uses a Class II pointer similar to ones used for pointing at slides during lectures.

Objectives:

To compare the angle difference between L-NASS (Method A) and the standard method (clinician intuition/conventional method)
To compare the angle difference between B-NASS (Method B) and the standard method (clinician intuition)
To compare the angle difference between the mobile device-NASS or MD-NASS (C) and the standard method (clinician intuition/conventional method)

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 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 or conventional method) 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 or conventional method) of CT-guided biopsy

Primary outcome for the third arm is:

--The difference between planned and achieved needle angle of a mobile device-assisted needle angle selection system with the standard method (clinician's intuition or conventional method) of CT-guided biopsy.

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 none of the 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 20, 2012

Actual Primary Completion Date :

Nov 16, 2016

Actual Study Completion Date :

Nov 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: B-NASS Block assisted needle angle selection system	Device: Needle angle measurement The tool for measuring the needle angles will be an FDA-approved EM tracking system. 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.
Experimental: L-NASS laser assisted needle angle selection system	Device: Needle angle measurement The tool for measuring the needle angles will be an FDA-approved EM tracking system. 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.
Experimental: MD-NASS mobile-device assisted needle angle selection system	Device: Needle angle measurement The tool for measuring the needle angles will be an FDA-approved EM tracking system. 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.

Arm

Intervention/Treatment

Experimental: B-NASS

Block assisted needle angle selection system

Device: Needle angle measurement

The tool for measuring the needle angles will be an FDA-approved EM tracking system. 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.

Experimental: L-NASS

laser assisted needle angle selection system

Device: Needle angle measurement

Experimental: MD-NASS

mobile-device assisted needle angle selection system

Device: Needle angle measurement

Outcome Measures

Primary Outcome Measures

Difference between L-NASS and standard method [Completion of study]
Data is currently undergoing analysis
Differnce between B-NASS and standard method [Completion of study]
Data is currently undergoing analysis
The difference between MD-NASS and standard method [Completion of study]
Data is currently undergoing analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

Patients must fulfill all of the following criteria to be eligible for study admission:

All patients must be undergoing a CT-guided biopsy.
Age greater than 18 years.
No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
Ability to follow breathing instructions like holding breath (if procedure is to be performed without general anesthesia).
Patients must be actively enrolled on an NIH protocol and be scheduled for a CT-guided biopsy.

EXCLUSION CRITERIA:

Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
Patients unlikely to be able to hold reasonably still on a procedure table for the length of the procedure.
Patients with any known allergy to plastics or polymers (since the Ultem -polymer could theoretically induce a rash in these patients, even though it is hypoallergenic).
Inability to follow breathing instructions, if without general anesthesia.
Patients with pacemakers or automatic implantable cardiac defibrillators.
Gross body weight above the CT table limit (450 pounds).