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Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 351 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 12 words
    • Publications: details revised at 11 of 11 entries
  2. Minor 4 versions Re-verified since Jun 27, 2026, no change to tracked fieldsv347-v350
  3. Notable Primary and study completion pushed from Jun 2, 2027 to Aug 2, 2028v346
  4. Notable Primary and study completion pushed from Jun 2, 2026 to Jun 2, 2027v345
  5. Minor 27 versions Re-verified since Jun 24, 2025, no change to tracked fieldsv318-v344
Show 16 earlier versionsHide 16 earlier versions
  1. Notable Primary and study completion dates: Jun 2, 2025 to Jun 2, 2026v317
  2. Minor 15 versions Re-verified since Mar 14, 2025, no change to tracked fieldsv302-v316
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 visualized by usual imaging techniques, such as computed tomography (CT) scans or ultrasound. Some lesions, such as certain liver or kidney tumors, small endocrine abnormalities, and others, may be hard to find or only visible for a few seconds. The new method uses a needle with a miniature tracking device buried inside the metal that tells where the tip of the needle is located, somewhat like a mini GPS, or global positioning system. It uses a very weak magnet to localize the device like a miniature satellite system. This study will explore whether this system can be used in the future to more accurately place the needle in or near the desired location or abnormality. 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....
Trial Details
NCT Number NCT00102544
Lead Sponsor National Institutes of Health Clinical Center (CC)
Conditions
(from sponsor)
Adenocarcinoma, Prostate Neoplasms, Prostate Cancer, Renal Cell Carcinoma, Von Hippel Lindau Disease
Related terms Adenocarcinoma, Carcinoma, Renal Cell, Prostatic Neoplasms, von Hippel-Lindau Disease
Enrollment 3,894 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov