Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms, Prostate Cancer
About this trial
This is an interventional device feasibility trial for Adenocarcinoma focused on measuring CT-Guided, Electromagnetic Tracking, Ultrasound-Guided Biopsy, Ablation, Surgical Navigation
Eligibility Criteria
INCLUSION CRITERIA: Patients must fulfill all of the following criteria to be eligible for study admission. Patient enrollment is by referral only. All patients must have a pre-operative imaging (CT, MR, or PET scan) available in digital format. Age greater than or equal to 18 years. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation. 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. All patients in non-prostate biopsy cohorts, must be undergoing an image-guided surgical or interventional radiology procedure such as an angiography or a CT/ US-guided biopsy as clinically indicated or IRB-approved under a separate research protocol. PROSTATE BIOPSY COHORT (Cohorts 1 and 9) INCLUSION CRITERIA: 1. Patients are eligible if they have undergone a prostate MRI and have had abnormalities identified as follows: PSA >2.5 OR abnormal digital rectal exam OR an abnormality identified on prostate MRI with a clinical indication for fusion biopsy Pre-biopsy prostate MRI showing targetable lesions EXCLUSION CRITERIA: Patients with any of the following will be excluded from study entry: Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure. Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia. Patients with pacemakers and other potentially electrically conductive implants. Gross body weight above the CT table limit (606 pounds), if CT table used.
Sites / Locations
- National Institutes of Health Clinical Center
Arms of the Study
Arm 1
Experimental
All cohorts (prostate biopsy percutaneous biopsy and ablation)
This study will consist of comparison of tracked imaging with near-simultaneous actual imaging .