RecruitingNot ApplicableNCT06322602

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

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


Sponsor

Mayo Clinic

Enrollment

20 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is placing a small device called an Ommaya reservoir in the brain of patients who are already having a biopsy for a suspected brain tumor. This device allows doctors to collect samples of cerebrospinal fluid (the fluid around the brain) over time without additional surgery, helping researchers track how the tumor changes. **You may be eligible if:** - You have signs and symptoms suggesting a brain tumor - You are already scheduled for a brain biopsy as part of your standard care at Mayo Clinic in Rochester, Minnesota - You are willing to have your Ommaya device sampled at least 2 more times in the future - You are 18 years or older and able to give your own consent **You may NOT be eligible if:** - You are under 18 years old - You are pregnant, a prisoner, or otherwise a vulnerable individual - You are not a suitable candidate for a biopsy due to other health reasons - You lack the mental capacity to consent for yourself Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntracranial Catheter Placement

Undergo Ommaya reservoir placement

PROCEDURELumbar Puncture

Undergo LP

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo CSF sample collection

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06322602


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