Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Jan 28, 2005

Keywords

ClinConnect Summary

Background:

The effectiveness of targeting lesions or a specific area 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 coul...

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Eligibility criteria

• * INCLUSION CRITERIA:
• • Patients must fulfill all of the following criteria to be eligible for study admission. Patient enrollment is by referral only.
• • 1. All patients must have a pre-operative imaging (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. 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:
• • 1. PSA \>2.5 OR abnormal digital rectal exam OR an abnormality identified on prostate MRI with a clinical indication for fusion 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. Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
• • 4. Patients with pacemakers and other potentially electrically conductive implants.
• • 5. Gross body weight above the CT table limit (606 pounds), if CT table used.