Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06322602

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

Led by Mayo Clinic · Updated on 2026-03-03

20

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Patient is willing to have cerebrospinal fluid banked through the neuro-oncology biorepository (requires a separate signature)
Not Eligible

You will not qualify if you...

  • Adults lacking capacity to consent
  • Vulnerable populations including pregnant women, prisoners, and individuals under 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 due to factors such as surgical anatomy, immunosuppression, elevated risk of wound infection from diabetes, smoking history, morbid obesity, or other concerns

AI-Screening

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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