A Comparison of Methods for Assisting Needle Angle Selection During Image-guided Tissue Biopsy
Conditions
Lung Neoplasms - Liver Neoplasms - Kidney Neoplasms - Cancer
Conditions: official terms
Kidney Neoplasms - Liver Neoplasms - Lung Neoplasms - Neoplasms
Conditions: Keywords
Biopsy, Surgical Navigation, Image-guided Therapy, CT- Guided Biopsy, Cancer
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Needle angle measurement
Type: Device
Overall Status
Recruiting
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.
Detailed Description
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: - 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).
Location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Status: Recruiting
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) - 800-411-1222 - prpl@mail.cc.nih.gov
Start Date
September 2010
Completion Date
August 2017
Sponsors
National Institutes of Health Clinical Center (CC)
Source
National Institutes of Health Clinical Center (CC)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page