Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
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|ClinicalTrials.gov Identifier: NCT00102544|
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2005
Last Update Posted : September 16, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma Prostate Neoplasms Prostate Cancer Renal Cell Carcinoma Von Hippel Lindau Disease||Device: EM Tracking||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3245 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Electromagnetic Tracking of Devices During Interventional Procedures|
|Actual Study Start Date :||February 23, 2005|
|Estimated Primary Completion Date :||January 2, 2022|
|Estimated Study Completion Date :||January 2, 2024|
Experimental: All cohorts (prostate biopsy percutaneous biopsy and ablation)
This study will consist of comparison of tracked imaging with near simultaneous actual imaging .
Device: EM Tracking
Utilizing electromagnetic tracking technology as a fusion and navigation tool for minimally invasive interventional procedures.
- Feasibility of using electromagnetic devices in different cohorts. [ Time Frame: Day 1 ]"TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))
- Success of ablation as determined by imaging [ Time Frame: 3 months ]Primary effectiveness (success of ablation in local tumor control or success of biopsy in diagnostic biopsy sample). Successful ablation equals complete tumor ablation with a 5mm-1cm margin of normal tissue (if possible; quantified by the lack of enhancement of intravenous contrast material at 3 month follow up CT)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102544
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Bradford J Wood, M.D.||National Institutes of Health Clinical Center (CC)|