NCT06322602 Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors
| NCT ID | NCT06322602 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Brain Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-02-28 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Terry C. Burns, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06322602 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06322602 currently recruiting?
Yes, NCT06322602 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT06322602 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06322602 clinical trial?
NCT06322602 is sponsored by Mayo Clinic. The principal investigator is Terry C. Burns, M.D., Ph.D. at Mayo Clinic in Rochester. The trial plans to enroll 30 participants.