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NCT Number: NCT06322602

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Terry C. Burns, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Intracranial Catheter Placement

Procedure

Undergo Ommaya reservoir placement

Lumbar Puncture

Procedure

Undergo LP

Other names: LP, spinal tap

Biopsy

Procedure

Undergo biopsy

Other names: BIOPSY_TYPE, Bx

Biospecimen Collection

Procedure

Undergo CSF sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Cerebrospinal Fluid Collection, CSF Collection, Specimen Collection

Computed Tomography

Procedure

Undergo CT

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: 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

Primary outcomes

  1. Feasibility of Ommaya reservoir placement

    Time frame: 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 outcomes

  1. Utility of Ommaya reservoir

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 21, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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