Clinical trial · Interventional
Ommaya Reservoir Placement for Brain Tumor Biomarker Access
NCT04692337CI-TRIAL-00121172recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative Ommaya Reservoir placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ommaya Reservoir placement
- description
- Subjects undergoing surgery for a confirmed or suspected brain tumor will have an Ommaya Reservoir placed at the time of surgery.
- interventionNames
- Procedure: Intra-operative Ommaya Reservoir placement
Primary outcomes (3)
- measure
- Collection of serial CSF samples for biobanking and biomarker discovery and validation - proportion of patients
- timeFrame
- Through study completion, approximately 42 days
- description
- Assessed by the proportion of patients for whom longitudinal CSF can be collected.
- measure
- Collection of serial CSF samples for biobanking and biomarker discovery and validation - number of times
- timeFrame
- Through study completion, approximately 42 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.