Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Recruiting now · Not applicable

Conditions studied: Brain Tumor

In brief

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.

Key facts

Study ID

NCT04692337

Run by

Mayo Clinic

People needed

100

Starts

2021-01-15

Expected to finish

2027-02-28

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years.
• Clinical and radiographic evidence suggesting a diagnosis of a brain tumor.
• Planned neurosurgical procedure 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.
• Patients is willing to have CSF banked through the neuro-oncology biorepository (requires a separate signature)

You may not qualify if…

• Vulnerable populations including pregnant women, prisoners and individuals <18 years old.
• Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness.
• Prior history of any wound infection
• Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons could (but need not necessarily) include factors related to surgical anatomy, clinical evidence of significant immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns.
• Any patient for whom a clinical contraindication exists to a lumbar puncture (LP) will be excluded from the LP portion of this protocol, but would still be eligible for an Ommaya reservoir if they meet the inclusion criteria of the study. For example, a patient with a large posterior fossa mass lesion at risk of herniation, or a patient with coagulopathy, or other contraindication to lumbar puncture would not be eligible to participate via use of lumbar puncture for CSF access

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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