Use of Tracking Devices to Locate Abnormalities During Invasive Procedures

NCT00102544 | Enrolling By Invitation FDA Device

• 2 other identifiers: 05009105-CC-0091
• Study Type: interventional
• Target: 3,894
• Locations: 1 country
• Sites: 1

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 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. 1.Small 1-cm plastic donuts are place on the skin with tape.
2. 2.A planning CT scan is done.
3. 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. 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. 5.A repeat CT is done as it normally is to look for the location of the needle.
6. 6.After the procedure the CT scans are examined to determine how well the new tool located the needle in the old scan.

Conditions

Prostate Neoplasms; Prostate Cancer; Renal Cell Carcinoma; Von Hippel Lindau Disease; Adenocarcinoma

Keywords

CT-Guided; Electromagnetic Tracking; Ultrasound-Guided Biopsy; Ablation; Surgical Navigation

Outcome Measures

Primary Outcomes (1)

• Feasibility of using electromagnetic devices in different cohorts.

  "TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))

  Day 1

Secondary Outcomes (1)

• Success of ablation as determined by imaging

  3 months

Study Arms (1)

All cohorts (prostate biopsy percutaneous biopsy and ablation)

EXPERIMENTAL

This study will consist of comparison of tracked imaging with near-simultaneous actual imaging .

Device: EM Tracking

Interventions

EM Tracking DEVICE

Utilizing electromagnetic tracking technology as a fusion and navigation tool for minimally invasive interventional procedures.

All cohorts (prostate biopsy percutaneous biopsy and ablation)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (11)

• Seiler PG, Blattmann H, Kirsch S, Muench RK, Schilling C. A novel tracking technique for the continuous precise measurement of tumour positions in conformal radiotherapy. Phys Med Biol. 2000 Sep;45(9):N103-10. doi: 10.1088/0031-9155/45/9/402.

  PMID: 11008969 BACKGROUND

• Frantz DD, Wiles AD, Leis SE, Kirsch SR. Accuracy assessment protocols for electromagnetic tracking systems. Phys Med Biol. 2003 Jul 21;48(14):2241-51. doi: 10.1088/0031-9155/48/14/314.

  PMID: 12894982 BACKGROUND

• Solomon SB, White P Jr, Wiener CM, Orens JB, Wang KP. Three-dimensional CT-guided bronchoscopy with a real-time electromagnetic position sensor: a comparison of two image registration methods. Chest. 2000 Dec;118(6):1783-7. doi: 10.1378/chest.118.6.1783.

  PMID: 11115473 BACKGROUND

• Ahdoot M, Naser-Tavakolian A, Heard JR, Williams C, Daneshvar M, Gomella P, Mallavarapu S, Siddiqui M, Nazmifar M, Shih J, Turkbey B, Wood B, Pinto P. Prostate-Specific Antigen Density to Select Magnetic Resonance Imaging-Targeted vs Combined Biopsy for Prostate Cancer Diagnosis: A Secondary Analysis of the Trio Study. J Urol. 2025 Jun;213(6):693-701. doi: 10.1097/JU.0000000000004480. Epub 2025 Feb 14.

  PMID: 39951686 DERIVED

• Borde T, Varble NA, Hazen LA, Saccenti L, Garcia C, Digennaro M, Gurram S, Pinto PA, Turkbey B, Wood BJ. Impact of Discordance Between Magnetic Resonance Imaging and Ultrasound Volume Measurements on Prostate Fusion Biopsy Outcomes. J Urol. 2025 Apr;213(4):428-436. doi: 10.1097/JU.0000000000004368. Epub 2024 Dec 10.

  PMID: 39657598 DERIVED

• Ahdoot M, Lebastchi AH, Long L, Wilbur AR, Gomella PT, Mehralivand S, Daneshvar MA, Yerram NK, O'Connor LP, Wang AZ, Gurram S, Bloom J, Siddiqui MM, Linehan WM, Merino M, Choyke PL, Pinsky P, Parnes H, Shih JH, Turkbey B, Wood BJ, Pinto PA; Trio Study Group. Using Prostate Imaging-Reporting and Data System (PI-RADS) Scores to Select an Optimal Prostate Biopsy Method: A Secondary Analysis of the Trio Study. Eur Urol Oncol. 2022 Apr;5(2):176-186. doi: 10.1016/j.euo.2021.03.004. Epub 2021 Apr 10.

  PMID: 33846112 DERIVED

• Ahdoot M, Wilbur AR, Reese SE, Lebastchi AH, Mehralivand S, Gomella PT, Bloom J, Gurram S, Siddiqui M, Pinsky P, Parnes H, Linehan WM, Merino M, Choyke PL, Shih JH, Turkbey B, Wood BJ, Pinto PA. MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis. N Engl J Med. 2020 Mar 5;382(10):917-928. doi: 10.1056/NEJMoa1910038.

  PMID: 32130814 DERIVED

• Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.

  PMID: 25626035 DERIVED

• Siddiqui MM, Rais-Bahrami S, Truong H, Stamatakis L, Vourganti S, Nix J, Hoang AN, Walton-Diaz A, Shuch B, Weintraub M, Kruecker J, Amalou H, Turkbey B, Merino MJ, Choyke PL, Wood BJ, Pinto PA. Magnetic resonance imaging/ultrasound-fusion biopsy significantly upgrades prostate cancer versus systematic 12-core transrectal ultrasound biopsy. Eur Urol. 2013 Nov;64(5):713-719. doi: 10.1016/j.eururo.2013.05.059. Epub 2013 Jun 12.

  PMID: 23787357 DERIVED

• Krucker J, Xu S, Venkatesan A, Locklin JK, Amalou H, Glossop N, Wood BJ. Clinical utility of real-time fusion guidance for biopsy and ablation. J Vasc Interv Radiol. 2011 Apr;22(4):515-24. doi: 10.1016/j.jvir.2010.10.033. Epub 2011 Feb 26.

  PMID: 21354816 DERIVED

• Krucker J, Xu S, Glossop N, Viswanathan A, Borgert J, Schulz H, Wood BJ. Electromagnetic tracking for thermal ablation and biopsy guidance: clinical evaluation of spatial accuracy. J Vasc Interv Radiol. 2007 Sep;18(9):1141-50. doi: 10.1016/j.jvir.2007.06.014.

  PMID: 17804777 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Adenocarcinoma; Prostatic Neoplasms; Carcinoma, Renal Cell; von Hippel-Lindau Disease

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Kidney Neoplasms; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Neurocutaneous Syndromes; Nervous System Diseases; Angiomatosis; Vascular Diseases; Cardiovascular Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Peter A Pinto, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2005
• First Posted: January 31, 2005
• Study Start: February 23, 2005
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-02-04

Locations

US (1)