Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - 120 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

3894 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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....

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institutes of Health Clinical Center (CC)

Study start

Feb 23, 2005 Actual

Primary completion

Aug 2, 2028 Estimated

Study completion

Aug 2, 2028 Estimated

First posted

Jan 31, 2005 Estimated

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.