A Comparison of Methods for Assisting Needle Angle Selection During Image-Guided Tissue Biopsy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- The difference between MD-NASS and standard method
研究概览
简要总结
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.
详细描述
Background:
- Currently, standard/conventional CT-guided biopsies proceed as follows the physician:
- obtains a pre-procedural CT scan,
- plans the needle s angle based on this CT scan,
- selects the angle at which the needle should be inserted based on the pre-procedural CT scan,
- inserts the needle while aiming to replicate that planned needle angle by using only their visual-spatial abilities, and
- re-images the patient to confirm needle location followed by needle
repositioning, if needed.
- Improving upon these standard methods of needle placement could have
widespread benefits (e.g. improved diagnostic tissue sampling, decreased
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
B-NASS
Block assisted needle angle selection system
干预措施: Needle angle measurement (Device)
L-NASS
laser assisted needle angle selection system
干预措施: Needle angle measurement (Device)
MD-NASS
mobile-device assisted needle angle selection system
干预措施: Needle angle measurement (Device)
结局指标
主要结局
The difference between MD-NASS and standard method
时间窗: Completion of study
Data is currently undergoing analysis
Difference between L-NASS and standard method
时间窗: Completion of study
Data is currently undergoing analysis
Differnce between B-NASS and standard method
时间窗: Completion of study
Data is currently undergoing analysis
次要结局
未报告次要终点