Electromagnetic Tracking of Devices During Interventional Procedures
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 3,894
- 试验地点
- 1
- 主要终点
- Feasibility of using electromagnetic devices in different cohorts.
研究概览
简要总结
This study will evaluate the accuracy and effectiveness of an experimental tracking device for locating abnormalities during invasive procedures, such as biopsy or ablation, that cannot easily be visualized by usual imaging techniques, such as computed tomography (CT) scans or ultrasound. Some lesions, such as certain liver or kidney tumors, small endocrine abnormalities, and others, may be hard to find or only visible for a few seconds. The new method uses a needle with a miniature tracking device buried inside the metal that tells where the tip of the needle is located, somewhat like a mini GPS, or global positioning system. It uses a very weak magnet to localize the device like a miniature satellite system. This study will explore whether this system can be used in the future to more accurately place the needle in or near the desired location or abnormality.
Patients 18 years of age and older who have a lesion that needs to be biopsied or an ablation procedure that requires CT guidance may be eligible for this study. Candidates are screened with a medical history and review of medical records, including imaging studies.
Participants undergo the biopsy or ablation procedure as they normally would, with the following exceptions: some stickers are placed on the skin before the procedure and a very weak magnet is placed nearby. The needles used are similar to the ones that would normally be used except that they contain a metal coil or spring buried deep within the needle metal. The procedure involves the following steps:
- Small 1-cm plastic donuts are place on the skin with tape.
- A planning CT scan is done.
- The CT scan is sent to the computer and matched to the patient's body location with the help of a very weak magnet.
- The needle used for the procedure is placed towards the target tissue or abnormality and the "smart needle" location lights up on the old CT scan.
- A repeat CT is done as it normally is to look for the location of the needle.
- After the procedure the CT scans are examined to determine how well the new tool located the needle in the old scan.
详细描述
Background:
The effectiveness of targeting lesions or a specific area for surgery, angiography, CT-guided, or ultrasound-guided biopsy, or ablation, currently may be limited by the visibility of a target during the procedure. Accurate therapeutic intervention may depend upon accurate device placement, which may be very difficult in certain settings, such as when a liver tumor only is visible for a brief moment in time during the transient arterial phase of a contrast injection, soon disappearing on dynamic imaging. Surgery, angiography, image guided therapies and diagnostic procedures could be vastly improved by enabling the use of pre-procedural imaging during the procedure [such as location of difficult to visualize or transiently visible targets].Tracking devices allow the use of preoperative imaging during the procedure. Having this information available could vastly improve targeting accuracy of surgery, angiography, CT-guided, or ultrasound-guided biopsy or ablation.
A method of improving targeting could potentially benefit patients in the future by reducing total radiation exposure during CT scan or fluoroscopic monitoring of a biopsy, or decreasing certain surgical risks, although these are not specific subjects of this study. Various methods of device tracking have been used in the past throughout the 20th and 21st century in neurosurgery with the use of stereotactic frames for a similar purpose, to register pre-operative imaging to the patient during invasive procedures to guide treatment.
Objectives:
To define the clinical utility of electromagnetic tracking during interventional procedures in specific patient populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（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. Patient enrollment is by referral only.
- •All patients must have a pre-operative imaging (CT, MR, or PET scan) available in digital format.
- •Age greater than or equal to 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.
- •All patients in non-prostate biopsy cohorts, must be undergoing an image-guided surgical or interventional radiology procedure such as an angiography or a CT/ US-guided biopsy as clinically indicated or IRB-approved under a separate research protocol.
- •PROSTATE BIOPSY COHORT (Cohorts 1 and 9) INCLUSION CRITERIA:
- •1. Patients are eligible if they have undergone a prostate MRI and have had abnormalities identified as follows:
- •PSA >2.5 OR abnormal digital rectal exam OR an abnormality identified on prostate MRI with a clinical indication for fusion biopsy
- •Pre-biopsy prostate MRI showing targetable lesions
排除标准
- •Patients with any of the following will be excluded from study entry:
- •Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
- •Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.
- •Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
- •Patients with pacemakers and other potentially electrically conductive implants.
- •Gross body weight above the CT table limit (606 pounds), if CT table used.
研究组 & 干预措施
All cohorts (prostate biopsy percutaneous biopsy and ablation)
This study will consist of comparison of tracked imaging with near-simultaneous actual imaging .
干预措施: EM Tracking (Device)
结局指标
主要结局
Feasibility of using electromagnetic devices in different cohorts.
时间窗: Day 1
"TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))
次要结局
- Success of ablation as determined by imaging(3 months)