Taking people in United StatesNo phase

Imaging coil placed inside the nose during pituitary tumor surgery

Tests a small imaging coil during surgery in adults with pituitary tumors.

Key facts

Who runs it: National Institute of Neurological Disorders and Stroke (NINDS)
Where: Bethesda, United StatesSee the site
Trial code: NCT03678389
Registry title: Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
Status: Recruiting
People taking part: 70 people, planned
Started: 9 May 2019
Expected to end: 1 Dec 2028
Type of study: Interventional
Treatments tested: ESC
Record updated: 29 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a known or suspected pituitary gland tumor who need surgery through the nose (transsphenoidal surgery). It tests placing a small MRI coil during surgery.

Age: More than 18 years, up to 85 years
Sex: All
Disease stage: Known or suspected pituitary tumor that needs removal by transsphenoidal surgery. Any size. Tumors growing into nearby structures can join.

Main reasons for not taking part

Body size or weight too large for the MRI table during surgery, such as severe obesity
Cannot have MRI or MRI contrast agent because of devices or conditions
Nose or skull anatomy that the surgeon thinks makes coil placement too risky
Pregnant or breastfeeding
Not enrolled in the NIH study 03-N-0164

The registry criteria, word for word

Show all 10 criteriaShow less

Other criteria

INCLUSION CRITIERIA:; Adult subjects (more than 18 years of age) will be included in this study if they:
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
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
Are able to provide written consent
NIH employees are included in the study; EXCLUSION CRITIERIA:; Subjects will be excluded from this study if they:
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
Have an absolute contraindication to MRI imaging or MRI contrast agent according to Rad\&IS screening including devices or conditions
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.)
Are pregnant or nursing
Patients older than 85 years of age. Cushing disease is rare in the older population

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 85 years old?

Where in United States

National Institutes of Health Clinical CenterBethesda, United StatesContact: Christina P Hayes, C.R.N.P.Taking people

About the trial

What the trial wants to find out

Tumors of the pituitary gland comprise up to 20% of all brain tumors. The central location and the small size of the pituitary gland make the management of tumors particularly challenging. Transsphenoidal surgery (TSS) to resect pituitary tumors is highly successful at achieving complete cure for functional pituitary adenomas. It is most successful when such adenomas can be localized by preoperative MRI of the pituitary. However, in some instances, small functional tumors cannot be visualized. In the case of Cushing s disease (CD), such non-visualization may be as high as 50%. The success of transsphenoidal surgery is substantially reduced in patients with negative MRI, as some of the adenomas that cause CD are so small that they are difficult to find during surgical exploration of the pituitary. Surgical success is also diminished when tumors invade the walls of the cavernous sinus. MRI of the pituitary lacks imaging resolution to detect such invasion and so the surgeon cannot perform a complete resection with surgery based on the preoperative MRI.

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Signal to noise ratio (SNR) is the primary constraint on achieving high quality high resolution MRI images. SNR can be improved by longer scan times or by increasing the field strength of the MRI magnet. SNR is proportional to the square of imaging time, however, long imaging times are not clinically feasible. SNR is linearly proportional to field strength, however, replacing MRI magnets is cost prohibitive.

Another strong determinant of SNR is the proximity of the MRI receiver coil to the tissue being imaged. Placement of a coil in close proximity to the structure of interest dramatically increases SNR, often as much as 10-fold. Clinically this is routinely put into practice for superficial body parts, such as the temporomandibular joints, in which small coils are placed directly over the joints to achieve rapid high-resolution imaging. For deep structures, the use of superficial coils is of no benefit. This has led to the development of endocavitary coils, such as the endorectal coil used to image the prostate gland. Such coils are now in routine clinical use here at the NIH and elsewhere.

During routine TSS, the surgical approach to the pituitary provides a route for placement of imaging tools, such as handheld ultrasound and Doppler probes in close proximity to the gland. Extending this model to MRI imaging, we realized that an endocavitary surface coil within the sphenoid sinus will allow for a marked improvement in SNR for imaging the sella. To this end, we have developed an endosphenoidal coil (ESC), demonstrated its MRI safety, and performed preliminary studies in cadaver heads to determine that the ESC can be placed through the transsphenoidal approach. Placement of ESC needs no modification in the surgical TSS approach to the pituitary gland. The goal of this protocol is to examine the safety and feasibility of ESC placement and imaging during TSS.