Status:
ENROLLING_BY_INVITATION
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Adenocarcinoma
Prostate Neoplasms
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
This study will evaluate the accuracy and effectiveness of an experimental tracking device for locating abnormalities during invasive procedures, such as biopsy or ablation, that cannot easily be visu...
Detailed Description
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 ta...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 23 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 2 2026
Estimated Enrollment :
3894 Patients enrolled
Trial Details
Trial ID
NCT00102544
Start Date
February 23 2005
End Date
June 2 2026
Last Update
January 5 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892