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Endosphenoidal Coil Placement for Pituitary Tumors

N/A

Recruiting

Led By Prashant Chittiboina, M.D.

Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult subjects (more than 18 years of age) with 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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study completion

Awards & highlights

Study Summary

This trialtests if a new coil device can improve MRI imaging of pituitary tumors during surgery, to help improve outcomes for pituitary tumor patients.

Who is the study for?

Adults aged 18-85 scheduled for pituitary tumor surgery at NIH can join. They must be able to consent and fit on the MRI table, without contraindications to MRI or its contrast agent. Pregnant or nursing individuals, those with variant anatomy posing risks, or over 85 are excluded.Check my eligibility

What is being tested?

The trial is testing a new device called an endosphenoidal coil (ESC) during transsphenoidal surgery. The ESC aims to improve MRI images of the pituitary gland and tumors in real-time during the operation.See study design

What are the potential side effects?

Potential side effects may include discomfort from lying still during MRI scans, reactions to the contrast dye like nausea or itching, and risks associated with standard surgical procedures such as infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult with a pituitary gland tumor needing surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of using ESC as a clinical tool during transsphenoidal surgery. Feasibility will be assessed by the time added to a standard TSS procedure.

Secondary outcome measures

Evaluate whether the use of ESC causes local trauma, bleeding, burns or other unanticipated safety issues during TSS.