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

Launched by MAYO CLINIC · Mar 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to collect important health information from patients with brain tumors. Researchers want to see if placing a small device called an Ommaya reservoir during a biopsy can help them gather samples of cerebrospinal fluid (CSF) over time. This fluid can provide valuable insights into how the tumor is growing and how well treatments are working. The Ommaya reservoir, which is implanted under the scalp, allows doctors to collect these samples without needing to perform a spinal tap each time, making the process easier for patients.

To be eligible for this study, participants must have been diagnosed with a brain tumor and are scheduled for a biopsy as part of their routine care. They also need to be willing to provide consent and agree to have their Ommaya reservoir sampled on at least two future occasions. Participants can expect to undergo the biopsy and have the reservoir placed, which will allow for easier collection of CSF samples later on. This study is important because it may help doctors find better ways to monitor brain tumors and tailor treatments to individual patients in the future.

Gender

ALL

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)
• • Adults lacking capacity to consent
• 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