Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

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Brief Title

Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

Official Title

Electromagnetic Tracking of Devices During Interventional Procedures

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.
    

Detailed Description

      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 pre-operative 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 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.

      Eligibility:

        1. All patients must have a pre-operative CT, MR, or PET scan performed at NIH.

        2. Age greater than 18 years.

        3. Patients must be actively enrolled on an NIH protocol and be scheduled for surgery,
           angiography, or CT- or ultrasound-guided biopsy.

      Design:

      This is an exploratory interventional study examining the use of a guidance system for
      navigating and monitoring devices like biopsy and ablation needles, ultrasound transducers,
      needle guides, guidewires, scalpels, and cauterization devices (herein referred to as
      device(s) ) for localization in relation to pre-operative images.There are 9 cohorts included
      in this protocol. The Open/Laparoscopic surgery and Angiography surgery cohorts are no longer
      open for accrual.

        1. Prostate biopsy

        2. Percutaneous biopsy for diagnostic correlation

        3. percutaneous ablation for needle placement compilations

        4. Open/Laparoscopic surgery

        5. Angiography

        6. Auto registration for biopsy

        7. Auto registration for ablation

        8. PET registration

        9. prostate biopsy on which to determine the predictive value and relative strength of each
           MRI sequence in predicting cancer at a specific prostate core location.

      The total accrual ceiling for this protocol is 3195 subjects.

      All cohorts open for accrual are using exploratory interventions to define the specific
      patient population where fusion used during interventional procedures may have clinical
      value, and to characterize that clinical value in a specific patient population, such as but
      not limited to patients with specific regions of the prostate targeted, specific prostate
      volumes, prior negative prostate biopsies, or PSA values within a specific range.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Feasibility of using electromagnetic devices in different cohorts.

Secondary Outcome

 Success of ablation as determined by imaging

Condition

Adenocarcinoma

Intervention

EM Tracking

Study Arms / Comparison Groups

 All cohorts (prostate biopsy percutaneous biopsy and ablation)
Description:  This study will consist of comparison of tracked imaging with near simultaneous actual imaging .

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

2584

Start Date

February 23, 2005

Completion Date

January 2, 2024

Primary Completion Date

January 2, 2022

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bradford J Wood, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00102544

Organization ID

050091

Secondary IDs

05-CC-0091

Responsible Party

Sponsor

Study Sponsor

National Institutes of Health Clinical Center (CC)


Study Sponsor

Bradford J Wood, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)


Verification Date

May 19, 2021