Tiny coil placed inside nose could help surgeons spot hidden brain tumors
NCT ID NCT03678389
First seen Jun 24, 2026 · Last updated Sep 02, 2026 · Updated 7 times
Summary
This study tests a small MRI coil placed inside the sphenoid sinus during pituitary tumor surgery. The goal is to see if it can provide clearer images of tiny tumors that standard MRI often misses. About 70 adults with pituitary tumors will take part. The coil is inserted through the same surgical opening used for the operation, and researchers will check for safety and image quality.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- endosphenoidal coil (ESC)
- What this could lead to
- If successful, this coil could help surgeons see tiny pituitary tumors during surgery, potentially improving removal rates and reducing the need for repeat procedures.
- What could go wrong
- This is a very early feasibility study with only 70 people. The coil may not provide clear enough images, or could cause minor bleeding or other issues during placement.
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 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2019
- Expected to finish
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Dec 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 85 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 CRITIERIA: Adult subjects (more than 18 years of age) will be included in this study if they: 1. Have a known or suspected tumor of the pituitary gland that requires surgical resection through a transsphenoidal approach. There is no size restriction. Invasion of surrounding anatomical structures by the pituitary tumor will not be ground for screen failure/withdrawal from study. 2. Are enrolled in 03-N-0164, Evaluation and Treatment of Neurosurgical Disorders. If not enrolled, subjects will not be able to be included in the study as clinical and research procedures are done under the 03-N-0164 protocol. 3. Are able to provide written consent. 4. NIH employees are included in the study. EXCLUSION CRITIERIA: Subjects will be excluded from this study if they: 1. Are unable to fit the intra-operative MRI table due to size or weight restrictions i.e morbid obesity. Patients will be anaesthetized and therefore claustrophobia will not be ground for screen failure/withdrawal from study. 2. Have an absolute contraindication to MRI imaging or MRI contrast agent according to Rad\&IS screening including devices or conditions. 3. Have a variant anatomy which may, in the judgment of the operating neurosurgeon, add unacceptable risk to the placement of the endosphenoidal coil (e.g. small size of facial bones and nasal passages, unaerated sphenoid sinus etc.). 4. Are pregnant or nursing. 5. Patients older than 85 years of age. Cushing disease is rare in the older population.
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
RECRUITINGBethesda, Maryland, 20892, United States