Status:
COMPLETED
A Comparison of Methods for Assisting Needle Angle Selection During Image-guided Tissue Biopsy
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Lung Neoplasms
Liver Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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. s...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
March 20 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01218854
Start Date
March 20 2012
End Date
November 16 2016
Last Update
September 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892