Using a new coil device to improve MRI imaging during pituitary tumor surgery

Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery

This study is testing a new device to see if it can improve MRI images during surgery for pituitary tumors, helping doctors find and remove the tumors more effectively.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT03678389 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the feasibility and safety of using an endosphenoidal coil (ESC) during transsphenoidal surgery for pituitary tumors. The ESC is designed to enhance MRI imaging quality by improving the signal-to-noise ratio, which is crucial for visualizing small tumors that may not be detectable with standard imaging techniques. Participants will be adults aged 18-85 who are undergoing surgery for pituitary tumors, and they will be screened through medical history, physical exams, and prior brain scans. The goal is to determine if the ESC can provide better imaging during surgery, potentially leading to more successful tumor resections.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-85 who have a known or suspected pituitary tumor requiring surgical resection.

Not a fit: Patients who are morbidly obese and unable to fit in the intra-operative MRI table will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes for patients with pituitary tumors by enabling better visualization and complete resection of tumors.

How similar studies have performed: While the use of advanced imaging techniques during surgery is common, the specific application of the endosphenoidal coil for this purpose is novel and has not been extensively tested in prior studies.

Eligibility criteria

* 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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Prashant Chittiboina, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
• Study coordinator: Christina P Hayes, C.R.N.P.

Conditions Pituitary Neoplasm; Pituitary Adenoma; pituitary surgery; Transsphenoidal Surgery; Pituitary Tumors