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

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ClinicalTrials.gov Identifier: NCT03678389
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pituitary Neoplasm Other: ESC Early Phase 1

  Show Detailed Description

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Study Type : Interventional
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
ENDOSPHENOIDAL COIL
Other: ESC
USE OF ENDOSPHENOIDAL COIL (ESC) TO OBTAIN MRI IMAGING OF THE PITUITARY GLAND




Primary Outcome Measures :
  1. Feasibility of using ESC as a clinical tool during transsphenoidal surgery.Feasibility will be assessed by the time added to a standard TSSprocedure. [ Time Frame: 2 hours ]
    The primary outcome of this study is the feasibility of using ESC as a clinical tool during transsphenoidal surgery. Feasibility will be assessed by the time added to a standard TSS procedure (measured from the time the TSS exposure is completed to the time to return to the operating position for completion of surgery).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678389


Contacts
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Contact: Gretchen C Scott, R.N. (301) 496-2921 gretchen.scott@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Prashant Chittiboina, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT03678389     History of Changes
Other Study ID Numbers: 180133
18-N-0133
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 7, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Pituitary Adenoma
pituitary surgery
Transsphenoidal Surgery
Pituitary Tumors
Additional relevant MeSH terms:
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Pituitary Neoplasms
Brain Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases