Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04692337

Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Led by Mayo Clinic · Updated on 2026-02-13

100

Participants Needed

1

Research Sites

319 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated operation for brain tumor. The Ommaya reservoir will facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of potential biomarkers for brain tumor research and individualized monitoring.

CONDITIONS

Official Title

Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Clinical and radiographic evidence suggesting a diagnosis of a brain tumor
  • Planned neurosurgical procedure for resection of suspected or previously diagnosed brain tumor as part of routine clinical care
  • Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN)
  • Willingness of the patient or an authorized representative to provide informed consent
  • Patient is willing to have their Ommaya sampled on at least 2 future occasions
  • Patient is willing to have CSF banked through the neuro-oncology biorepository (requires a separate signature)
Not Eligible

You will not qualify if you...

  • Vulnerable populations including pregnant women, prisoners, and individuals <18 years old
  • Patients not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness
  • Prior history of any wound infection
  • Any patient the surgeon feels is not an optimal candidate for Ommaya reservoir placement, including factors like surgical anatomy, immunosuppression, or elevated wound infection risk due to diabetes, smoking history, morbid obesity, or other concerns
  • Patients with contraindications to lumbar puncture (e.g., large posterior fossa mass at risk of herniation, coagulopathy) will be excluded from the lumbar puncture portion but may still be eligible for Ommaya reservoir placement if other criteria are met

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

E

Essa Sharif

CONTACT

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Ommaya Reservoir Placement for Brain Tumor Biomarker Access | DecenTrialz