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Ommaya Reservoir Placement for Brain Tumor Biomarker Access

This study is looking at the safety and practicality of placing an Ommaya Reservoir during brain tumor surgery. An Ommaya Reservoir is a small device put under your scalp that allows doctors to easily collect cerebrospinal fluid (CSF) over time. The goal is to see if this device can help researchers collect CSF samples to find and test markers (biomarkers) that could lead to better ways to understand and monitor brain tumors. You may be able to join if you are over 18, have a suspected or diagnosed brain tumor, and are planning to have surgery at Mayo Clinic in Rochester, MN. The study will measure how many patients successfully have the reservoir placed, how many times CSF is collected, and the amount of CSF collected over about 42 days.

Study design
This is an interventional study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo an Ommaya Reservoir placement during your planned brain tumor surgery. CSF samples would be collected at two or more timepoints.
Compensation
Not stated in the trial record.
Follow-up
CSF samples will be collected and analyzed through study completion, which is approximately 42 days after the procedure.

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NCT04692337

Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Recruiting
NAAges 18+InterventionalBasic science
Mayo Clinic
~100 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Intra-operative Ommaya Reservoir placement

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Collection of serial CSF samples for biobanking and biomarker discovery and validation - proportion of patients
Measured over Through study completion, approximately 42 days
+2 more outcomes measured

Conditions

Brain Tumor

Explore related trials

Brain Neoplasm

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Terry C. Burns, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Essa Sharif
[email protected]
507-538-6342
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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.

What this trial measures

  • Collection of serial CSF samples for biobanking and biomarker discovery and validation - proportion of patientsThrough study completion, approximately 42 days

    Assessed by the proportion of patients for whom longitudinal CSF can be collected.

  • Collection of serial CSF samples for biobanking and biomarker discovery and validation - number of timesThrough study completion, approximately 42 days

    Assessed by the number of times longitudinal CSF collection occurred

  • Collection of serial CSF samples for biobanking and biomarker discovery and validation - volume obtainedThrough study completion, approximately 42 days

    Assessed by the volumes obtained at each Ommaya tap.