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

NCT03678389 | Recruiting

• 2 other identifiers: 18013318-N-0133
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Pituitary Neoplasm

Keywords

Pituitary Adenoma; pituitary surgery; Transsphenoidal Surgery; Pituitary Tumors

Outcome Measures

Primary Outcomes (2)

• Safety of ESC as an Intraoperative Adjunct Tool

  We hypothesize that using ESC is safe for patients undergoing TSS. We will monitor for adverse events that may arise due to the insertion, use and removal of the ESC. The surgical corridor will be monitored for bleeding, burns, physical trauma or impingement during insertion of ESC (by direct observation) and during imaging (via video feed), and after removal of the ESC (by direct observation). The adverse events will be graded as follows: Grade 0 uneventful deployment of the ESC; Grade I adverse events due to ESC deployment without any intra-operative consequences; Grade II adverse events due to ESC deployment needing surgical interventions (e.g. control of bleeding, modification of surgical approach, need for blood transfusion etc.) or burn injuries needing surgical management; Grade III severe adverse events due to ESC deployment needing immediate termination of the surgical procedure or permanent physical/neurologic injury due to impingement.

  Ongoing

• Feasibility of ESC as a Clinical Tool

  Clinical utility will be evaluated by a board certified neuroradiologist. The utility measure is a binary outcome measure (yes/no). The neuroradiologist will also make additional subjective observations about the image quality, image resolution, imaging artifacts and image noise. For patients with microadenomas, the primary outcome measure will be the accuracy of the ESC in detecting previously detected microadenomas. A positive outcome measure will be denoted if a possible microadenoma is detected with the ESC in the same location as detected by pre-operative MRI imaging. For patients with pituitary macroadenomas, the primary outcome will be detection of invasion of the cavernous sinus and ability to detect intra-tumoral heterogeneity. For patients with MRI negative pituitary disease, the primary outcome measure will be the ability to detect adenomas. At the conclusion of enrollment, all images will be reviewed by an independent board-certified neuroradiologist.

  Ongoing

Study Arms (1)

1

EXPERIMENTAL

ENDOSPHENOIDAL COIL

Other: ESC

Interventions

ESC OTHER

USE OF ENDOSPHENOIDAL COIL (ESC) TO OBTAIN MRI IMAGING OF THE PITUITARY GLAND

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Prashant Chittiboina, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina P Hayes, C.R.N.P.

CONTACT

(301) 496-2921; christi.hayes@nih.gov

Prashant Chittiboina, M.D.

CONTACT

(301) 496-2921; prashant.chittiboina@nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: May 9, 2019
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04-20

Locations

US (1)