Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Study Overview
=================
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 facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of potential biomarkers for brain tumor research and individualized monitoring.

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, behavior and the efficacy of candidate therapies. Although multiple studies have evaluated CSF from patients with brain tumors, very few have collected CSF at multiple timepoints throughout the course of disease. However, multiple samples over time are needed to determine if candidate biomarkers accurately reflect the evolution of disease. CSF is typically obtained via lumbar puncture which is inconvenient and often uncomfortable. This protocol will evaluate the safety and feasibility of placing Ommaya reservoirs at the time of surgery. It is anticipated that reducing barriers to CSF access through placement of an Ommaya reservoir may expedite brain tumor research and facilitate the development of individualized treatment strategies. An Ommaya Reservoir will be placed during a planned brain tumor operation. Following the routine portion of the planned procedure, the Ommaya reservoir will be placed under the scalp with the catheter tip placed either within the ventricle or the resection cavity. Presence of the Ommaya reservoir will enable CSF to be easily accessed at any time in the future. It is expected that CSF will be collected at 2 or more timepoints. CSF will be stored in the Mayo Clinic neuro-oncology biorepository and made available in a de-identified manner for multiple research projects. The patient and his/her provider(s) may take advantage of the Ommaya reservoir and/or banked CSF samples to facilitate participation in any relevant IRB-approved research study(s), and/or to facilitate individualized management. The details of each time the Ommaya is accessed will be documented as part of this trial.

Official Title
-----------------
Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Conditions
-----------------
Brain Tumor

Intervention / Treatment
-----------------
* Procedure: Intra-operative Ommaya Reservoir placement


Participation Criteria
=================
Eligibility 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). Ability to understand and the willingness to sign a written informed consent document. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ommaya Reservoir placement<br>Subjects undergoing surgery for a confirmed or suspected brain tumor will have an Ommaya Reservoir placed at the time of surgery. | Procedure: Intra-operative Ommaya Reservoir placement<br>* An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events of intra-operative Ommaya Reservoir placement | Number of subjects to develop persistent adverse events deemed related (possibly, probably, definitely) to the insertion or use of Ommaya Reservoirs. Adverse events will be measured by CTCAE 5.0. | through study completion, approximately 42 days | 
| Intra-operative Ommaya Reservoir placement | Number of subjects whom Ommaya reservoir is successfully placed at the time of surgery without complication. | through study completion, approximately 42 days |