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

Mayo Clinic

Status: Enrolling

Conditions: Brain Neoplasms

Treatments: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Lumbar Puncture; Procedure: Intracranial Catheter Placement; Procedure: Biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06322602

NCI-2024-01762 (Registry Identifier)

23-009112

R33NS122096 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Exclusion criteria

• Adults lacking capacity to consent
• 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ommaya reservoir placement

Experimental group

Description:

Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also optionally undergo lumbar puncture while on study. Patients also undergo CT or MRI on study.

Treatment:

Procedure: Biopsy

Procedure: Intracranial Catheter Placement

Procedure: Lumbar Puncture

Procedure: Magnetic Resonance Imaging

Procedure: Computed Tomography

Procedure: Biospecimen Collection