View Clinical Trial (Medical Research Study)
Electromagnetic Tracking of Devices During Interventional Procedures: A Pilot Study
| City: |
|
Bethesda |
| State: |
|
Maryland |
| Zip Code: |
|
20892 |
| Conditions: |
|
Unspecified Adult Solid Tumor, Protocol Specific |
| Purpose: |
|
RATIONALE: Electromagnetic device tracking may help in planning diagnostic procedures and
cancer treatment.
PURPOSE: This clinical trial is studying electromagnetic device tracking to see how well it
works in patients undergoing CT-guided biopsy or ablation.
|
| Study Summary: |
|
OBJECTIVES:
- To determine the feasibility, accuracy, and registration error of electromagnetic
device tracking in patients undergoing CT-guided biopsy or ablation.
- To determine if targeted plus conventional biopsy is superior to conventional biopsy
alone in diagnosing subjects with prostate cancer.
- To perform composite analysis of all needle insertions during RFA to facilitate optimal
needle placement during the ablation procedure.
- To correlate different needle locations with diagnosis, quality of specimens, and
imaging features.
OUTLINE: Three to 6 multimodality adhesive fiducial markers (about 1 cm in diameter) are
placed on the skin near the region of interest. Patients then undergo planning
contrast-enhanced CT scan. The images are transferred to a computer and matched to the
patient's body location by clicking on the fiducial marker on the image while simultaneously
placing the electromagnetic tracking device on the actual selected fiducial marker on the
patient's body. Patients then undergo CT-guided biopsy or ablation using a needle that
contains the electromagnetic tracking device. Spatial data, registration errors, and
navigation errors of the electromagnetic tracking device are recorded.
|
| Criteria: |
|
DISEASE CHARACTERISTICS:
- Actively enrolled on an NIH clinical trial AND is scheduled to undergo CT-guided
biopsy or ablation of a lesion
- PSA > 2.5 ng/mL or abnormal digital rectal exam (for prostate biopsy cohort)
- Pre-biopsy prostate MRI with endorectal coil and showing targetable lesions (for
prostate biopsy cohort)
PATIENT CHARACTERISTICS:
- Not pregnant
- Negative pregnancy test
- Able to hold breath (if procedure will be performed with conscious sedation and
without general anesthesia)
- Able to hold reasonably still on a procedure table for the length of the procedure
- Gross body weight must not be above the CT scan table limit (375 pounds)
- No known allergy to adhesives or latex
- No skin reactions to dressings
- No pacemakers or automatic implantable cardiac defibrillators
- No uncorrectable coagulopathies
- No multiple comorbid illnesses, sepsis, or multiple high-risk medical problems
- No concurrent serious medical illness or altered mental status that would preclude
giving informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
|
| NCT ID: |
|
NCT00671840 |
| Primary Contact: |
|
Principal Investigator
Bradford Wood, MD
National Cancer Institute (NCI)
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Bethesda, Maryland 20892
United States
Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 25, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|