Menu
Recruiting NCT06322602

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

No phase Interventional Brain Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intracranial Catheter Placement, Lumbar Puncture, Biopsy, Biospecimen Collection.
Who it may be relevant to
Registry conditions: Brain Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Intracranial Catheter Placement
    Undergo Ommaya reservoir placement
  • Procedure Lumbar Puncture
    Undergo LP
  • Procedure Biopsy
    Undergo biopsy
  • Procedure Biospecimen Collection
    Undergo CSF sample collection
  • Procedure Computed Tomography
    Undergo CT
  • Procedure Magnetic Resonance Imaging
    Undergo MRI

Primary outcome measures

  • Feasibility of Ommaya reservoir placement [Time frame: Up to 5 years]
Secondary outcome measures (1)
  • Utility of Ommaya reservoir [Time frame: Up to 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06322602 · 23-009112 · R33NS122096 · R01CA315861

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗