Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors

Not Applicable

Recruiting

• Conditions: Brain Neoplasms
• Interventions: Procedure: Intracranial Catheter Placement; Procedure: Lumbar Puncture; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography

• Registration Number: NCT06322602
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-28
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2029-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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
• Patients is willing to have CSF banked through the neuro-oncology biorepository (requires a separate signature)
• Adults lacking capacity to consent

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ommaya reservoir placement	Biopsy	Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also undergo lumbar puncture while on study. Patients also undergo CT on study.
Ommaya reservoir placement	Biospecimen Collection	Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also undergo lumbar puncture while on study. Patients also undergo CT on study.
Ommaya reservoir placement	Intracranial Catheter Placement	Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also undergo lumbar puncture while on study. Patients also undergo CT on study.
Ommaya reservoir placement	Lumbar Puncture	Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also undergo lumbar puncture while on study. Patients also undergo CT on study.
Ommaya reservoir placement	Computed Tomography	Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also undergo lumbar puncture while on study. Patients also undergo CT on study.

Primary Outcome Measures

Name	Time	Method
Feasibility of Ommaya reservoir placement	Up to 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Utility of Ommaya reservoir	Up to 5 years	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States