Placement of Ommaya Reservoir for Brain Tumor Biomarker Access
Official title: Ommaya Reservoir Placement for Brain Tumor Biomarker Access
Run by Mayo Clinic · NCT04692337 · Data updated 2026-11-12
This study is testing if placing a small device called an Ommaya Reservoir during brain tumor surgery can help doctors easily collect fluid samples to better understand the tumor and improve treatment for patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | January 15, 2021 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT04692337 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with a clinical diagnosis of a brain tumor who are scheduled for neurosurgery at the Mayo Clinic.
✕Probably not a fit
Patients who are not suitable for surgery or have a history of wound infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the safety and feasibility of placing an Ommaya Reservoir during surgery for brain tumors. The reservoir will allow for easy and repeated access to cerebrospinal fluid (CSF) for biomarker analysis, which is crucial for understanding tumor behavior and treatment efficacy. By collecting CSF samples at multiple timepoints, researchers hope to gain insights that could lead to more personalized treatment strategies for brain tumor patients. The study will be conducted at the Mayo Clinic, where the reservoir will be placed under the scalp during the routine surgical procedure.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the ability to monitor brain tumors and tailor treatments to individual patients.
How similar studies have gone: While there have been studies on CSF collection, the use of Ommaya Reservoirs for longitudinal access in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Terry C. Burns, MD, PhD — Mayo Clinic
- Study coordinator: Essa Sharif
- Email: sharif.essa@mayo.edu
- Phone: 507-538-6342
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.