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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Pituitary Adenoma;
pituitary surgery;
Transsphenoidal Surgery;
Pituitary Tumors

Recruitment Keyword(s)

None

Condition(s)

Pituitary Neoplasm

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: ENDOSPHENOIDAL COIL

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

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 18-65 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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Eligibility

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 65 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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Prashant Chittiboina, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Sarah M. Benzo
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 3D20
10 Center Drive
Bethesda, Maryland 20892
(301) 496-2921
sarah.benzo@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03678389

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