This study is currently recruiting participants.
Number
18-N-0133
Sponsoring Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 85 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Pituitary Adenoma; pituitary surgery; Transsphenoidal Surgery; Pituitary Tumors
Recruitment Keyword(s)
None
Condition(s)
Pituitary Neoplasm
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Other: ESC
Supporting Site
National Institute of Neurological Disorders and Stroke
Pituitary tumors can cause problems by secreting hormones in the body. They can also problems by growing large and pushing on organs near the pituitary gland. The best treatment for such tumors is to remove them by surgery. But that may be sometimes difficult. Some tumors maybe too small to see. Some other tumors maybe so large that portions maybe left behind during surgery. The endosphenoidal coil (ESC) is a new magnetic resonance imaging (MRI) device. It fits in a small space made during surgery near the pituitary. Researchers want to see if it helps transmit MRI signals during surgery to make better images of the pituitary gland and tumors.
Objective:
To test the safety of using a new coil device to improve MRI imaging of pituitary tumors during surgery.
Eligibility:
Adults 18-85 years old who are having pituitary tumor surgery at NIH
Design:
Participants will be screened with:
-Medical history
-Physical exam
-Review of prior brain scans
-Blood and pregnancy tests
All participants will have MRI of pituitary gland. They will lie on a table that slides into a metal cylinder in a strong magnetic field. They will lie still and get earplugs for loud sounds. A dye will be inserted into an arm vein by needle.
Participants will stay in the hospital for about 1 week. They will repeat screening tests.
Participants will have standard pituitary surgery. They will get medicine to go to sleep. The surgeon will create a path to the pituitary gland from under the lip.
During surgery, the ESC will be placed through the path to near the pituitary. Then an MRI will be done during surgery.
Then the ESC will be removed and standard surgery will continue.
Participants will get standard post-operative care under another protocol.
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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. The Eligibility Checklist is included as an attachment. This checklist is used by the investigator at the time of screening for admission to the protocol.
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.
The Eligibility Checklist is included as an attachment. This checklist is used by the investigator at the time of screening for admission to the protocol.
Principal Investigator
Referral Contact
For more information: