Ommaya Reservoir Placement for Brain Tumor Biomarker Access

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor
• Intervention / Treatment: Procedure: Intra-operative Ommaya Reservoir placement

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Essa Sharif; Phone Number: 507-538-6342; Email: sharif.essa@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Terry C. Burns, MD, PhD
      • Contact: Essa Sharif; Phone Number: 507-538-6342; Email: sharif.essa@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ommaya Reservoir placement; 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; An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of serial CSF samples for biobanking and biomarker discovery and validation - proportion of patients	Assessed by the proportion of patients for whom longitudinal CSF can be collected.	Through study completion, approximately 42 days
Collection of serial CSF samples for biobanking and biomarker discovery and validation - number of times	Assessed by the number of times longitudinal CSF collection occurred	Through study completion, approximately 42 days
Collection of serial CSF samples for biobanking and biomarker discovery and validation - volume obtained	Assessed by the volumes obtained at each Ommaya tap.	Through study completion, approximately 42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of 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 Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Through study completion, approximately 42 days
Scope of CSF biomarkers	Assessed by the number of assays run for each patient and the number of times the assays successfully detected an analyte under consideration as a candidate biomarker.	Through study completion, approximately 42 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Terry C. Burns, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 20-009226; NCI-2021-02766 (Other Identifier: CTRP (Clinical Trials Reporting Program)); R33NS122096 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Protocol details and individualized de-identified patient data will be provided as supplemental files in the resulting publication. Any additional information not otherwise provided may be requested from the primary investigator.
• IPD Sharing Time Frame: Any time after publication.
• IPD Sharing Access Criteria: Requests will be honored that could help advance the care of patients with brain tumors.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No