NCT04692337

Ommaya Reservoir Placement for Brain Tumor Biomarker Access

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Intra-operative Ommaya Reservoir placement	An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.

Timeline

• Start date: 2021-01-15
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2020-12-31
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States