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

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Neoplasms; Cancer; Lung Neoplasms; Liver Neoplasms
• Intervention / Treatment: Device: Needle angle measurement

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.) 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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between L-NASS and standard method	Data is currently undergoing analysis	Completion of study
Differnce between B-NASS and standard method	Data is currently undergoing analysis	Completion of study
The difference between MD-NASS and standard method	Data is currently undergoing analysis	Completion of study

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Bradford J Wood, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

General Publications

• Miaux Y, Guermazi A, Gossot D, Bourrier P, Angoulvant D, Khairoune A, Turki C, Bouche E. Laser guidance system for CT-guided procedures. Radiology. 1995 Jan;194(1):282-4. doi: 10.1148/radiology.194.1.7997570.
• Pereles FS, Baker M, Baldwin R, Krupinski E, Unger EC. Accuracy of CT biopsy: laser guidance versus conventional freehand techniques. Acad Radiol. 1998 Nov;5(11):766-70. doi: 10.1016/s1076-6332(98)80260-2.
• Jacobi V, Thalhammer A, Kirchner J. Value of a laser guidance system for CT interventions: a phantom study. Eur Radiol. 1999;9(1):137-40. doi: 10.1007/s003300050644.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2012
• Primary Completion (Actual): November 16, 2016
• Study Completion (Actual): November 16, 2016

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimated): October 11, 2010

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: May 28, 2024

More Information

Terms related to this study

• Keywords: Cancer; Biopsy; Surgical Navigation; Image-guided Therapy; CT- Guided Biopsy
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Digestive System Neoplasms; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms; Kidney Neoplasms; Lung Neoplasms; Liver Neoplasms
• Other Study ID Numbers: 100217; 10-CC-0217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .It is not yet known if there will be a plan to make IPD available and still undecided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No