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NCT03678389 · ClinicalTrials.gov registry record · NA
Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
A NA study of Pituitary Neoplasm, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT03678389 is a NA study of Pituitary Neoplasm that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 70 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03678389, a NA study of Pituitary Neoplasm, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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 18-85 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.
Conditions Studied
Interventions
- OTHER ESC
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-05-09 |
| Est. Completion | 2028-12-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03678389
The ClinicalTrials.gov registry entry for NCT03678389 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pituitary Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which ESC is the first listed.
NCT03678389 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03678389 about?
NCT03678389 is a clinical study titled "Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery". 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 smal...
What is the current status of trial NCT03678389?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2019-05-09. Estimated completion is 2028-12-01.
What conditions does trial NCT03678389 study?
This clinical trial studies the following conditions: Pituitary Neoplasm.
What interventions are being tested in trial NCT03678389?
The interventions under investigation include: ESC (OTHER).
Who is sponsoring clinical trial NCT03678389?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03678389 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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