Electromagnetic Tracking of Devices During Interventional Procedures

Trial Information

Electromagnetic Tracking of Devices During Interventional Procedures

Background:

The effectiveness of targeting lesions 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 surgery and
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, except those undergoing RFA or prostate biopsy must be actively enrolled on
an NIH protocol and be scheduled for surgery, angiography, or CT- or ultrasound-guided
biopsy.

Design:

This is a pilot 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.

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 and

7) 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.