At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Comparison of Methods for Assisting Needle Angle Selection During Image-Guided Tissue Biopsy
In Brief
A Phase 1 clinical trial evaluating Needle angle measurement for Lung Neoplasms and 3 related conditions. Completed, enrolled 17 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.