This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor.
Clinical and radiographic evidence suggesting a diagnosis of a brain tumor
Planned biopsy for suspected or previously diagnosed brain tumor as part of routine clinical care at Mayo Clinic (Rochester, Minnesota [MN])
Willingness of the patient to provide informed consent
Patient is willing to have their Ommaya sampled on at least 2 future occasions
Vulnerable populations including pregnant women, prisoners, and individuals < 18 years old
Patients who are not appropriate candidates for biopsy due to current or past medical history or uncontrolled current illness
Prior history of any wound infection
Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons may include, but will not be limited to, surgical anatomy, clinical evidence of immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns
Single group
Intracranial Catheter Placement
Procedure/SurgeryUndergo Ommaya reservoir placement
Lumbar Puncture
Procedure/SurgeryUndergo LP
Biopsy
Procedure/SurgeryUndergo biopsy
Biospecimen Collection
Procedure/SurgeryUndergo CSF sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Feasibility of Ommaya reservoir placement
Will be assessed based on the percent of patients for whom an Ommaya reservoir is successfully placed at the time of tissue biopsy without attributable complication.
Utility of Ommaya reservoir
Will be assessed based on the percent of patients for whom multiple (2 or more) cerebrospinal fluid (CSF) samples are successfully obtained as a result of their participation in this protocol.
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Mayo Clinic
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
National Cancer Institute (NCI)
Collaborator
