NCT04692337 Ommaya Reservoir Placement for Brain Tumor Biomarker Access
| NCT ID | NCT04692337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Brain Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-01-15 |
| Primary Completion | 2027-02-28 |
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 100 participants in total. It began in 2021-01-15 with a primary completion date of 2027-02-28.
⚠ 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
The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated operation for brain tumor. The Ommaya reservoir will facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of potential biomarkers for brain tumor research and individualized monitoring.
Eligibility Criteria
Inclusion Criteria: * Age \> 18 years. * Clinical and radiographic evidence suggesting a diagnosis of a brain tumor. * Planned neurosurgical procedure resection of suspected or previously diagnosed brain tumor as part of routine clinical care. * Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN). * Willingness of the patient or an authorized representative 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 surgery due to current or past medical history or uncontrolled concurrent illness. * Prior history of any wound infection * Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons could (but need not necessarily) include factors related to surgical anatomy, clinical evidence of significant immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns. * Any patient for whom a clinical contraindication exists to a lumbar puncture (LP) will be excluded from the LP portion of this protocol, but would still be eligible for an Ommaya reservoir if they meet the inclusion criteria of the study. For example, a patient with a large posterior fossa mass lesion at risk of herniation, or a patient with coagulopathy, or other contraindication to lumbar puncture would not be eligible to participate via use of lumbar puncture for CSF access
Contact & Investigator
Terry C. Burns, MD, PhD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04692337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04692337 currently recruiting?
Yes, NCT04692337 is actively recruiting participants. Contact the research team at sharif.essa@mayo.edu for enrollment information.
Where is the NCT04692337 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04692337 clinical trial?
NCT04692337 is sponsored by Mayo Clinic. The principal investigator is Terry C. Burns, MD, PhD at Mayo Clinic. The trial plans to enroll 100 participants.