Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06322602

Conditions

Brain Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intracranial Catheter Placement

Lumbar Puncture

Biopsy

Biospecimen Collection

Computed Tomography

Study Details

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

Study ID

NCT06322602

Start date

Feb 28, 2024

Status verified date

Aug, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ommaya reservoir placement

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.

Interventions

Intracranial Catheter Placement

Undergo Ommaya reservoir placement

Lumbar Puncture

Undergo LP

Biopsy

Undergo biopsy

Biospecimen Collection

Undergo CSF sample collection

Computed Tomography

Undergo CT

Magnetic Resonance Imaging

Undergo MRI

Primary outcome measure

  • Feasibility of Ommaya reservoir placement [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

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

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-05.