Mini GPS in a needle could help doctors hit hidden tumors
NCT ID NCT00102544
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 6 times
Summary
This study tests a special needle with a tiny tracking device inside, like a mini GPS, to help doctors find tumors that are hard to see on CT scans. About 3,900 adults with certain cancers or growths will have their biopsy or ablation procedure done using this smart needle. The goal is to see if the system can accurately guide the needle to the right spot, potentially making these procedures more precise.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Electromagnetic tracking device (GPS-like needle guidance system)
- What this could lead to
- If successful, this technology could make biopsies and tumor ablations more accurate and safer by helping doctors precisely target hard-to-see lesions.
- What could go wrong
- This is an early feasibility study focused on accuracy, not treatment outcomes. The device may not improve success rates or reduce complications in real-world use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 3,894 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2005
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
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- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?