Placement of an Ommaya reservoir during biopsy for brain tumor patients
Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection
This study is testing whether placing a small device under the scalp during a brain tumor biopsy can help doctors collect fluid samples over time to better understand how the tumor is growing and responding to treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06322602 on ClinicalTrials.gov |
What this trial studies
This observational trial evaluates the use of an Ommaya reservoir, a small device implanted under the scalp, during a biopsy to facilitate the longitudinal collection of cerebrospinal fluid (CSF) biomarkers in patients with brain tumors. The study aims to determine the effectiveness of this minimally invasive approach for monitoring tumor growth and response to therapy over time. By allowing for repeated sampling of CSF without the need for additional spinal taps, the trial seeks to enhance our understanding of tumor behavior and treatment efficacy. The ultimate goal is to identify biomarkers that could guide personalized treatment strategies for brain tumor patients.
Who should consider this trial
Good fit: Ideal candidates are adults with clinical and radiographic evidence of a brain tumor who are scheduled for a biopsy at Mayo Clinic.
Not a fit: Patients who are not appropriate candidates for biopsy or those with certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved monitoring and treatment strategies for patients with brain tumors.
How similar studies have performed: Other studies have shown promise in using similar biomarker collection techniques, but this specific approach with the Ommaya reservoir is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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: * 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 * 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Terry C. Burns, M.D., Ph.D. — Mayo Clinic in Rochester
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.