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

NCT01218854 | Completed Phase 1

• 2 other identifiers: 10021710-CC-0217
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms; Liver Neoplasms; Kidney Neoplasms; Cancer

Keywords

Biopsy; Surgical Navigation; Image-guided Therapy; CT- Guided Biopsy; Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

B-NASS

EXPERIMENTAL

Block assisted needle angle selection system

Device: Needle angle measurement

L-NASS

EXPERIMENTAL

laser assisted needle angle selection system

Device: Needle angle measurement

MD-NASS

EXPERIMENTAL

mobile-device assisted needle angle selection system

Device: Needle angle measurement

Interventions

Needle angle measurement DEVICE

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.

B-NASS; L-NASS; MD-NASS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 7997570 BACKGROUND

• 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.

  PMID: 9809074 BACKGROUND

• 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.

  PMID: 9933397 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Lung Neoplasms; Liver Neoplasms; Kidney Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Bradford J Wood, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 11, 2010
• Study Start: March 20, 2012
• Primary Completion: November 16, 2016
• Study Completion: November 16, 2016
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (1)