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RECRUITINGINTERVENTIONAL

Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - 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) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Intra-operative Ommaya Reservoir placement

An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.

Locations (1)

Mayo Clinic in Rochester
Rochester, Minnesota, United States