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

NCT01218854 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-09-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Bradford J Wood, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-20
Primary Completion
2016-11-16
Completion
2016-11-16

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218854 on ClinicalTrials.gov