Can a new MRI needle make biopsies more precise?
NCT ID NCT07783698
First seen Aug 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This study tests an investigational needle designed for use during MRI-guided procedures. The needle helps doctors reach specific areas of the body to take tissue samples or inject fluids. The trial will check if the needle works safely and effectively in patients who need such procedures for tumors, masses, or other conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cook® iMRI Needle, an investigational MRI-compatible needle for percutaneous access, aspiration, or injection during interventional MRI procedures.
- What this could lead to
- If successful, this needle could make MRI-guided biopsies and injections safer and more precise, improving diagnostic accuracy and treatment delivery.
- What could go wrong
- This is a small early study with only 10 participants, so results may not apply broadly. Risks include procedural complications like bleeding or infection, and the needle may not perform as expected.
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.
- Participants
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10 people
The number who actually took part.
- Started
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Jan 2026
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Clinically appropriate patients who can willing participate in research.
- Ages
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18 years and older
- 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: Patient is suitable for inclusion in the study if the patient meets the following criteria: 1. A qualified physician directs the patient to have a procedure that requires a needle for percutaneous access, aspiration, and/or injection during therapeutic or diagnostic interventional MRI-guided procedures 2. Patients, or their legally authorized representatives, must also voluntarily consent to participate in the study Exclusion Criteria: 1. Inability or refusal to give informed consent by the patient or legally authorized representative 2. Age \< 18 years 3. Vulnerable population (specifically prisoners, lactating women and/or cognitively impaired patients) 4. Patients lacking a safe trajectory to the target tissue, as determined by the physician 5. Patients with uncorrectable coagulopathy 6. Allergy to the device or contrast media that cannot be adequately premedicated 7. Body habitus or medical condition that compromises or prevents necessary imaging procedures 8. Body weight exceeding limits of available MRI machines 9. Target lesion is unable to be reached by the longest needle (or in combination with a core biopsy device) 10. Implanted non-MR conditional device or other metallic device (e.g., certain pacemakers, aneurysm clips, cochlear implants, and/or mechanical heart valves) 11. Inability of the patient to cooperate with, or to be positioned for, the procedure
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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.
Contacts and locations
Locations
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University of Michigan Medicine
Ann Arbor, Michigan, 48109, United States