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

NCT06322602 | Recruiting DMC

• 3 other identifiers: 23-009112NCI-2024-01762R33NS122096
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms

Outcome Measures

Primary Outcomes (1)

• Feasibility of Ommaya reservoir placement

  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.

  Up to 5 years

Secondary Outcomes (1)

• Utility of Ommaya reservoir

  Up to 5 years

Study Arms (1)

Ommaya reservoir placement

EXPERIMENTAL

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.

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

Interventions

Intracranial Catheter Placement PROCEDURE

Undergo Ommaya reservoir placement

Ommaya reservoir placement

Lumbar Puncture PROCEDURE

Undergo LP

Also known as: LP, spinal tap

Ommaya reservoir placement

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Ommaya reservoir placement

Biospecimen Collection PROCEDURE

Undergo CSF sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Cerebrospinal Fluid Collection, CSF Collection, Specimen Collection

Ommaya reservoir placement

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Ommaya reservoir placement

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, Structural MRI, sMRI

Ommaya reservoir placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Spinal Puncture; Biopsy; Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Terry C. Burns, M.D., Ph.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)