Ommaya Reservoir Placement for Brain Tumor Biomarker Access
ConditionBrain Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Intra-operative Ommaya Reservoir placement
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Mayo Clinic
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov