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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01218854
First received: October 8, 2010
Last updated: June 10, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Lung Neoplasms
Liver Neoplasms
Kidney Neoplasms
Cancer
Device: Laser-Assisted Angle Selection System
Device: Block-Assisted Angle Selection System
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Comparison of Methods for Assisting Needle Angle Selection During Image-Guided Tissue Biopsy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The angle error (the difference between the planned needle angle and the actual needle angle recorded prior to biopsy procedure).
  • The primary outcome measure will be the angle error (the difference between the planned needle angle and the actual needle angle recorded prior to biopsy procedure).

Estimated Enrollment: 30
Study Start Date: September 2010
Intervention Details:
    Device: Laser-Assisted Angle Selection System
    N/A
    Device: Block-Assisted Angle Selection System
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218854

Contacts
Contact: Charisse Garcia, R.N. (301) 594-4511 garciacr@mail.nih.gov
Contact: Bradford Wood, M.D. (301) 496-7739 bwood@mail.cc.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Bradford Wood, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01218854     History of Changes
Other Study ID Numbers: 100217, 10-CC-0217
Study First Received: October 8, 2010
Last Updated: June 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Biopsy
Surgical Navigation
Image-guided Therapy
CT- Guided Biopsy
Cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Liver Neoplasms
Lung Neoplasms
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Kidney Diseases
Liver Diseases
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014