Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Launched by MAYO CLINIC · Dec 29, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a procedure called Ommaya reservoir placement, which is done during surgery for brain tumors. The goal is to see if this method is safe and practical. The Ommaya reservoir is a device that allows doctors to access cerebrospinal fluid (the fluid around the brain and spinal cord) over time. This will help researchers study potential markers that can provide important information about brain tumors and help tailor treatment for individual patients.

To be eligible for this trial, participants must be at least 18 years old and have evidence of a brain tumor that requires surgery. They should be willing to have their Ommaya reservoir accessed for testing on at least two occasions after the surgery and agree to have some of their cerebrospinal fluid stored for research purposes. Participants can expect to undergo a routine surgical procedure at Mayo Clinic in Rochester, MN, and they will be closely monitored throughout the process. This study will not include people who are pregnant, prisoners, or those who may not be suitable candidates for surgery due to health issues.

Gender

ALL

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).
• • Ability to understand and the willingness to sign a written informed consent document.
• • 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.