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

RecruitingNAAges 18 Years - 85 YearsAllNational Institute of Neurological Disorders and …
NCT03678389 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
* 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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What it tests

  • ESC
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Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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