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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intracranial Catheter Placement
  • Lumbar Puncture
  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mayo Clinic

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator