跳至主要内容
临床试验/NCT03678389
NCT03678389招募中不适用

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

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Safety of ESC as an Intraoperative Adjunct Tool

研究概览

简要总结

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.

详细描述

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 a 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, 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 gland provides a route for the 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 would 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. The 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.

Objective

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

ENDOSPHENOIDAL COIL

干预措施: ESC (Other)

结局指标

主要结局

Safety of ESC as an Intraoperative Adjunct Tool

时间窗: Ongoing

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.

Feasibility of ESC as a Clinical Tool

时间窗: Ongoing

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.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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