Ommaya Reservoir Placement for Brain Cancer
Recruiting in Palo Alto (17 mi)
Overseen byTerry C. Burns, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Pregnancy, Prisoners, Under 18, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Ommaya Reservoir Placement for Brain Cancer?
The Ommaya reservoir is effective in delivering drugs directly to the brain, bypassing the blood-brain barrier, which is a major obstacle in treating brain conditions. It has been successfully used for conditions like leptomeningeal metastases and other intracranial malignancies, with studies showing a low complication rate and effective drug delivery.
12345How is Ommaya reservoir placement different from other brain cancer treatments?
Ommaya reservoir placement is unique because it allows for direct delivery of chemotherapy into the brain's ventricles, which can be more effective for treating cancer that has spread to the central nervous system. This method is different from traditional chemotherapy, which is usually given through the bloodstream and may not reach the brain as effectively.
13467Eligibility Criteria
Adults over 18 with a suspected or diagnosed brain tumor who are undergoing surgery at Mayo Clinic in Rochester, MN. Participants must be willing to sign consent forms and allow their cerebrospinal fluid (CSF) to be collected for research. Pregnant women, prisoners, minors, those not fit for surgery due to medical history or illness, and individuals with infection risks like diabetes or smoking are excluded.Inclusion Criteria
Ability to understand and the willingness to sign a written informed consent document
I am willing to have brain surgery at Mayo Clinic in Rochester, MN.
I am older than 18 years.
+4 more
Exclusion Criteria
I cannot have surgery due to my health condition or another serious illness.
I have had an infection in a wound before.
The surgeon doesn't think it's a good idea to place the Ommaya reservoir in the patient for reasons like the patient's anatomy, weakened immune system, or high risk of infection due to health conditions like diabetes, smoking, or obesity.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgery and Ommaya Reservoir Placement
Ommaya Reservoir is placed during a planned brain tumor operation to facilitate CSF access
1 day
1 visit (in-person)
CSF Collection and Monitoring
CSF is collected at 2 or more timepoints for biomarker analysis and individualized monitoring
6 weeks
Follow-up
Participants are monitored for safety and effectiveness after Ommaya Reservoir placement
6 weeks
Participant Groups
The trial is testing the safety of placing an Ommaya Reservoir into the brain during tumor removal surgery. This device will provide ongoing access to CSF for biomarker analysis and monitoring throughout the treatment process.
1Treatment groups
Experimental Treatment
Group I: Ommaya Reservoir placementExperimental Treatment1 Intervention
Subjects undergoing surgery for a confirmed or suspected brain tumor will have an Ommaya Reservoir placed at the time of surgery.
Intra-operative Ommaya Reservoir placement is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Ommaya reservoir for:
- Administration of intrathecal chemotherapy for brain tumors
- Chronic drainage of CSF for infants with intraventricular hemorrhage
- Administration of opioid pain medications
🇪🇺 Approved in European Union as Ommaya reservoir for:
- Administration of intrathecal chemotherapy for brain tumors
- Chronic aspiration of fluid from tumor cysts not amenable to treatment
- Administration of IT antibiotics for chronic relapsing meningitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
Loading ...
Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Ommaya reservoirs for the treatment of leptomeningeal metastases. [2022]Ommaya reservoirs are frequently used to deliver intraventricular chemotherapy in cancer patients with leptomeningeal metastases. We review techniques of catheter placement and complication avoidance.
Optimal use of the Ommaya reservoir in clinical oncology. [2005]A major obstacle to the effective systemic therapy of intracranial malignancies and infections, the bloodbrain barrier was overcome by the development of the Ommaya reservoir in 1963. Initially used in treating cryptococcal meningitis, this closed system for continued access to the ventricular spaces has a variety of applications. They include treatment of cancer pain, chronic or recurrent CNS infection, prophylaxis of CNS involvement in acute lymphoblastic leukemia, and treatment of leptomeningeal malignancy. The authors outline the rationale, latest indications, surgical technique, and potential complications arising from the use of the Ommaya reservoir and other such subcutaneous reservoirs.
Navigation-guided Ommaya reservoir placement: implications for the treatment of leptomeningeal metastases. [2016]Ommaya reservoirs are commonly used in the diagnosis and management of leptomeningeal metastases (LM) from malignant tumors. The present study investigates the utility of an intraoperative navigation-guided technique for Ommaya reservoir placement. Between March 2004 and December 2005, 85 navigation-guided Ommaya reservoir placements were performed in 77 patients with intracranial malignancies at the Komagome Metropolitan Hospital. Anterior horn puncture and posterior horn puncture were used for 59 and 26 procedures, respectively. A slit ventricle was present in 6 cases. All procedures were performed under assistance from the Medtronic STEALTH STATION TRIA navigation system. Computed tomographic (CT) scans were routinely obtained just after completion of the procedure. Patients diagnosed with LM received subsequent treatment. An Ommaya catheter was applied to the ventricular puncture needle registered in the navigation system and was inserted into the lateral ventricle. Using the real-time "Guidance View", the surgeon was able to verify the catheter position continuously during the procedure. Postoperative CT scan revealed an appropriate catheter position in all except for one case. Complications (catheter malposition) occurred in only one case (complication rate, 1.2%). None of the patients experienced hemorrhage or infection. In conclusion, navigation-guided Ommaya reservoir placement was associated with a very low incidence of complications. This method appears to be safe and effective when employed in patients with intracranial malignancy.
Nursing management of patients with an implanted Ommaya reservoir. [2013]The Ommaya reservoir (NeuroCare Group, Pleasant Prairie, WI) is an implanted ventricular device that permits delivery of drugs directly into the central nervous system (CNS). It is used in the management of patients whose cancer has invaded or may potentially invade the CNS; for pain management; for treatment of CNS infection; for monitoring of CNS pressure; and for cerebrospinal fluid sampling. Nursing care related to the Ommaya reservoir includes assessing patients, providing patient and family education, and, in some situations, accessing the device.
Experience with Ommaya reservoir in 120 consecutive patients with meningeal malignancy. [2019]The Ommaya Reservoir plays an important role in a select group of neuro-oncology patients with meningeal malignancy. The benefits derived must be balanced against potential complications associated with insertion and use of the apparatus. Side effects may be minimized by careful attention to patient selection, pre-operative CAT scan (or MRI), precise surgical technique, perioperative prophylactic antibiotics and meticulous procedure during use of the reservoir.
Ommaya Reservoir Insertion: A Technical Note. [2020]Ommaya reservoir insertion is an elective neurosurgical procedure to deliver repeated intraventricular therapy, but placement can be complicated by malposition of the catheter, clogging, infection or poor postoperative cosmesis. Here, we describe the technique used by the senior author for accurate placement including preassembly of the reservoir and catheter, and recessing of the reservoir so that others may consider the technique for their practice. Results in a consecutive series of 27 Ommaya placements were reviewed. Catheter tip placement accuracy, complications and surgical times were reported. Indications were leptomeningeal cancer or infection. Postoperative imaging showed the catheter tip was located in the frontal horn (96%) or body (4%) of the ipsilateral lateral ventricle. The median surgical time was 36 minutes (range 17-63 minutes). There were no parenchymal or subarachnoid hemorrhages. Infections occurred in 7% (n=2) of cases, and both infections presented greater than 60 days postoperative. In conclusion, we have found that image guidance can optimize accuracy in placement, that preassembly of the reservoir and catheter may be used with a 25-gauge spinal needle stylet to minimize risk of clogging during placement, and that recessing of the reservoir produces the best aesthetic result.
Image Guidance for Placement of Ommaya Reservoirs: Comparison of Fluoroscopy and Frameless Stereotactic Navigation in 145 Patients. [2018]Ommaya reservoirs are used for administration of intrathecal chemotherapy and cerebrospinal fluid sampling. Ventricular catheter placement for these purposes requires a high degree of accuracy. Various options exist to optimize catheter placement. We analyze a cohort of patients receiving catheters using 2 different technologies.