This study is currently recruiting participants.
Number
05-CC-0091
Sponsoring Institute
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Enrolling by Invitation Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
Children
Keywords
CT-Guided; Electromagnetic Tracking; Ultrasound-Guided Biopsy; Ablation
Recruitment Keyword(s)
Surgical Navigation
Condition(s)
Adenocarcinoma; Prostate Neoplasms; Prostate Cancer; Renal Cell Carcinoma; Von Hippel Lindau Disease
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Device: EM Tracking
Supporting Site
NIH Clinical Center
Patients 18 years of age and older who have a lesion that needs to be biopsied or an ablation procedure that requires CT guidance may be eligible for this study. Candidates are screened with a medical history and review of medical records, including imaging studies.
Participants undergo the biopsy or ablation procedure as they normally would, with the following exceptions: some stickers are placed on the skin before the procedure and a very weak magnet is placed nearby. The needles used are similar to the ones that would normally be used except that they contain a metal coil or spring buried deep within the needle metal. The procedure involves the following steps:
1. Small 1-cm plastic donuts are place on the skin with tape.
2. A planning CT scan is done.
3. The CT scan is sent to the computer and matched to the patient's body location with the help of a very weak magnet.
4. The needle used for the procedure is placed towards the target tissue or abnormality and the "smart needle" location lights up on the old CT scan.
5. A repeat CT is done as it normally is to look for the location of the needle.
6. After the procedure the CT scans are examined to determine how well the new tool located the needle in the old scan.
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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. All patients in non-prostate biopsy cohorts, must be undergoing a surgical or interventional radiology procedure such as an angiography or a CT/ US-guided biopsy 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: a. PSA >2.5 or Abnormal digital rectal exam or an abnormality identified on prostate MRI witha clinical indication for biopsy. b. 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.
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. All patients in non-prostate biopsy cohorts, must be undergoing a surgical or interventional radiology procedure such as an angiography or a CT/ US-guided biopsy 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:
a. PSA >2.5 or Abnormal digital rectal exam or an abnormality identified on prostate MRI witha clinical indication for biopsy.
b. 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.
Principal Investigator
Referral Contact
For more information: