Ommaya Reservoir Placement for Brain Tumor Biomarker Access

NCT ID: NCT04692337

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2027-02-28

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.

Conditions

Brain Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Ommaya Reservoir placement

Subjects undergoing surgery for a confirmed or suspected brain tumor will have an Ommaya Reservoir placed at the time of surgery.

Group Type: EXPERIMENTAL

Intra-operative Ommaya Reservoir placement

Intervention Type: PROCEDURE

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

Interventions

Intra-operative Ommaya Reservoir placement

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

Intervention Type: PROCEDURE

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).
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terry C. Burns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Essa Sharif

Role: CONTACT

sharif.essa@mayo.edu

507-538-6342

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Facility Contacts

Essa Sharif

Role: primary

sharif.essa@mayo.edu

507-538-6342

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

R33NS122096

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2021-02766

Identifier Type: OTHER

Identifier Source: secondary_id

20-009226

Identifier Type: -

Identifier Source: org_study_id