Electromagnetic Tracking of Devices During Interventional Procedures
18 Years
N/A
Both
Tomography, Emission-Computed
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.
Inclusion 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. Patients, except for those in enrolling in Cohorts 1 and 9, must be actively enrolled
in an NIH protocol.
6. For surgery cohort, patients must be undergoing a surgical procedure 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.
Type of Study:
Observational
Study Design:
N/A
Principal Investigator
Bradford Wood, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Institutes of Health Clinical Center (CC)
Authority:
United States: Federal Government
Study ID:
050091
NCT ID:
NCT00102544
Start Date:
January 2005
Completion Date:
Related Keywords:
- Tomography, Emission-Computed
- Magnetic Tracking
- Surgical Navigation
- Image-guided Therapy
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
