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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Intra-operative Ommaya Reservoir placement
Procedure/SurgeryAn Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Ommaya Reservoir placementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Collection of serial CSF samples for biobanking and biomarker discovery and validation - proportion of patients
Assessed by the proportion of patients for whom longitudinal CSF can be collected.
Time frame
Through study completion, approximately 42 days2
Collection of serial CSF samples for biobanking and biomarker discovery and validation - number of times
Assessed by the number of times longitudinal CSF collection occurred
Time frame
Through study completion, approximately 42 days3
Collection of serial CSF samples for biobanking and biomarker discovery and validation - volume obtained
Assessed by the volumes obtained at each Ommaya tap.
Time frame
Through study completion, approximately 42 daysSecondary outcomes
1
Incidence of Adverse Events of intra-operative Ommaya Reservoir placement
Number of subjects to develop persistent adverse events deemed related (possibly, probably, definitely) to the insertion or use of Ommaya Reservoirs. Adverse events will be measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Through study completion, approximately 42 days2
Scope of CSF biomarkers
Assessed by the number of assays run for each patient and the number of times the assays successfully detected an analyte under consideration as a candidate biomarker.
Time frame
Through study completion, approximately 42 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov