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Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

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ClinicalTrials.gov Identifier: NCT00102544
Recruitment Status : Recruiting
First Posted : January 31, 2005
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

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:

  1. Small 1-cm plastic donuts are place on the skin with tape.
  2. A planning CT scan is done.
  3. The CT scan is sent to the computer and matched to the patient's body location with the help of a very weak magnet.
  4. 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.
  5. A repeat CT is done as it normally is to look for the location of the needle.
  6. 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3195 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Electromagnetic Tracking of Devices During Interventional Procedures
Study Start Date : January 27, 2005
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : January 2, 2022


Arm Intervention/treatment
Experimental: prostate biopsy
Patients with prostate cancer. Patients will be defined and the benefit will be characterized within specific subset populations, such as in patients with prior negative biopsies, anterior targets, or PSA in specific ranges
Device: EM Tracking
Utilizing electromagnetic tracking technology as a fusion and navigation tool for minimally invasive interventional procedures.
Experimental: percutaneous biopsy and ablation
Patients with other cancers.
Device: EM Tracking
Utilizing electromagnetic tracking technology as a fusion and navigation tool for minimally invasive interventional procedures.



Primary Outcome Measures :
  1. 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))


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients must fulfill all of the following criteria to be eligible for study admission:

  1. All patients must have a CT, MR, or PET scan available in digital format.
  2. Age greater than or equal to 18 years.
  3. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
  4. 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.
  5. 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:

  1. PSA >2.5 or Abnormal digital rectal exam or an abnormality identified on prostate MRI witha clinical indication for biopsy.
  2. Pre-biopsy prostate MRI showing targetable lesions.

EXCLUSION CRITERIA:

Patients with any of the following will be excluded from study entry:

  1. Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
  2. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.
  3. 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.
  4. Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
  5. Patients with pacemakers or automatic implantable cardiac defibrillators.
  6. Gross body weight above the CT table limit (375 pounds), if CT table used.

Information from the National Library of Medicine

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


Contacts
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

Locations
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   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Principal Investigator: Bradford Wood, M.D. National Institutes of Health Clinical Center (CC)

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
First Posted: January 31, 2005    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 1, 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
Carcinoma, Renal Cell
Prostatic Neoplasms
Von Hippel-Lindau Disease
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases
Neurocutaneous Syndromes
Nervous System Diseases
Angiomatosis
Vascular Diseases
Cardiovascular Diseases