Status:
RECRUITING
Ommaya Reservoir Placement for Brain Tumor Biomarker Access
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Brain Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 fa...
Detailed Description
Most brain tumors remain incurable. Progress in clinical trials to identify better treatments has been slow. We hypothesize that longitudinal CSF access can provide insights regarding tumor identity, ...
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.
- 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
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04692337
Start Date
January 15 2021
End Date
February 28 2027
Last Update
September 15 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905