Bethesda, Maryland 20892


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: February 04, 2019

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