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New treatment option for Pituitary Neoplasm
Official title Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
ClinicalTrials.gov ID: NCT03678389
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- INCLUSION CRITIERIA: Adult people (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...
- Are enrolled in 03-N-0164, Evaluation and Treatment of Neurosurgical Disorders. If not enrolled, people will not be able to be included in the study...
- Are able to provide written consent.
- NIH employees are included in the study. EXCLUSION CRITIERIA: people will be excluded from this study if they:
See the full eligibility criteria
- INCLUSION CRITIERIA: Adult people (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...
- Are enrolled in 03-N-0164, Evaluation and Treatment of Neurosurgical Disorders. If not enrolled, people will not be able to be included in the study as clinical and research procedures are done under the 03-N-0164...
- Are able to provide written consent.
- NIH employees are included in the study. EXCLUSION CRITIERIA: people 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...
- 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...
- Are pregnant or nursing.
- Patients older than 85 years of age. Cushing disease is rare in the older population.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.