IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|
| Adenocarcinoma Prostate Neoplasms |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Electromagnetic Tracking of Devices During Interventional Procedures |
- To define the clinical utility of electromagnetic tracking during surgery and interventional procedures in specific patient populations [ Time Frame: Completion of study ]
| Estimated Enrollment: | 3195 |
| Study Start Date: | January 26, 2005 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
Patients must fulfill all of the following criteria to be eligible for study admission:
- All patients must have a 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 a surgical or interventional radiology procedure such as an angiography or a CT/ US-guided biopsy and have pre-operative imaging.
PROSTATE BIOPSY COHORT (Cohorts 1 and 9) INCLUSION CRITERIA:
1. Source of patients will be the community at large as well as patients who have undergone prostate MRI and have had abnormalities identified as follows:
- PSA >2.5 or Abnormal digital rectal exam or an abnormality identified on prostate MRI witha clinical indication for biopsy.
- Pre-biopsy prostate MRI showing targetable lesions.
EXCLUSION CRITERIA:
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.
- Patients with any known allergy to adhesives or latex or skin reactions to dressings (since the adhesive fiducials could theoretically induce a rash in these patients), if adhesive fiducials are to be used.
- Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
- Patients with pacemakers or automatic implantable cardiac defibrillators.
- Gross body weight above the CT table limit (375 pounds), if CT table used.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00102544
| Contact: Charisse Garcia, R.N. | (301) 594-4511 | garciacr@mail.nih.gov | |
| Contact: Bradford Wood, M.D. | (301) 496-7739 | bwood@mail.cc.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Bradford Wood, M.D. | National Institutes of Health Clinical Center (CC) |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00102544 History of Changes |
| Obsolete Identifiers: | NCT00671840 |
| Other Study ID Numbers: |
050091 05-CC-0091 |
| Study First Received: | January 29, 2005 |
| Last Updated: | June 30, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
CT-Guided Electromagnetic Tracking Ultrasound-Guided Biopsy Ablation Surgical Navigation |
Additional relevant MeSH terms:
|
Adenocarcinoma Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on July 17, 2017