Ommaya Reservoir Placement for Brain Cancer

Overseen By Essa Sharif

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Prisoners, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and feasibility of placing an Ommaya reservoir during brain tumor surgery. An Ommaya reservoir is a small device that allows doctors to collect fluid from around the brain to study and monitor the tumor over time. This could lead to better understanding and personalized treatment for brain tumors. It suits individuals undergoing surgery for a confirmed or suspected brain tumor and willing to participate in follow-up fluid sampling. Participants must plan their surgery at Mayo Clinic in Rochester, MN. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially improve future brain tumor treatments.

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 prior data suggests that the Ommaya Reservoir placement is safe for brain tumor patients?

Research has shown that Ommaya reservoirs are generally well-tolerated by patients. These devices have been used in individuals with brain tumors for a long time. One study reported their use for nearly 200,000 days across many patients, with serious problems being rare. Specifically, only one major issue occurred in that study.

The surgery to place an Ommaya reservoir is considered safe. Doctors use advanced techniques, such as electromagnetic neuronavigation, to ensure accurate placement, reducing risks during the procedure and preventing harm to the brain.

Overall, past experiences and studies suggest that placing an Ommaya reservoir is safe for patients undergoing brain tumor surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ommaya Reservoir placement because it offers a direct method to deliver chemotherapy into the cerebrospinal fluid, which surrounds the brain and spinal cord. Unlike traditional systemic chemotherapy, which circulates throughout the body, this method allows for higher concentrations of medication to reach the brain without increasing systemic side effects. This precise delivery system could potentially improve treatment effectiveness for brain tumors, making it a promising option in the fight against brain cancer.

What evidence suggests that the Ommaya Reservoir placement is effective for brain cancer?

Studies have shown that the Ommaya reservoir is a safe and effective tool for managing brain conditions. A 20-year review involving children with brain tumors reported over 5,400 drug treatments administered through Ommaya reservoirs without major safety issues. Research indicates that using an Ommaya reservoir reduces the risk of problems like infection and malfunction compared to other methods. The reservoir delivers medications directly to the brain, potentially improving treatment for brain tumors. Additionally, it allows doctors to access cerebrospinal fluid (CSF), aiding in monitoring tumor changes over time. Participants in this trial will undergo Ommaya reservoir placement during surgery for a confirmed or suspected brain tumor. ^{1 3 6 7 8}

Who Is on the Research Team?

Terry C. Burns, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Intra-operative Ommaya Reservoir placement

Trial Overview

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.

How Is the Trial Designed?

Group I: Ommaya Reservoir placement Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Ommaya reservoir is an implanted device that allows for direct drug delivery into the central nervous system, which is crucial for managing cancers that affect the CNS, pain relief, and treating CNS infections.

Nursing care for patients with an Ommaya reservoir involves patient assessment, education for families, and accessing the device when necessary, highlighting the importance of comprehensive care in the management of these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing management of patients with an implanted Ommaya reservoir. Kosier, MB., Minkler, P.[2013]

In a review of 27 Ommaya reservoir placements, the catheter tip was accurately positioned in the frontal horn or body of the lateral ventricle in 100% of cases, demonstrating the effectiveness of the described technique.

The procedure had a low complication rate, with only 7% of cases resulting in infection, which occurred more than 60 days post-surgery, indicating a generally safe approach for delivering intraventricular therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ommaya Reservoir Insertion: A Technical Note. Magill, ST., Choy, W., Nguyen, MP., et al.[2020]

The Ommaya reservoir, developed in 1963, provides a method to bypass the blood-brain barrier, allowing for effective treatment of intracranial malignancies and infections, initially used for cryptococcal meningitis.

This closed system has diverse applications, including managing cancer pain, treating chronic CNS infections, preventing CNS involvement in leukemia, and addressing leptomeningeal malignancy, although it does come with potential complications that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal use of the Ommaya reservoir in clinical oncology. Sundaresan, N., Suite, ND.[2005]

The Ommaya Reservoir is beneficial for neuro-oncology patients with meningeal malignancies, providing a method for drug delivery directly to the cerebrospinal fluid.

To minimize complications associated with its use, careful patient selection, pre-operative imaging, precise surgical techniques, and the use of prophylactic antibiotics are essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with Ommaya reservoir in 120 consecutive patients with meningeal malignancy. Perrin, RG., Lishner, M., Guha, A., et al.[2019]

In a study of 107 cancer patients, the use of Ommaya reservoirs for delivering intraventricular chemotherapy showed a median survival of 9 months for those with leptomeningeal metastases, highlighting its potential efficacy in this patient population.

Complications occurred in 9.3% of patients, including infections and catheter malpositions, but these risks can be reduced through intraoperative techniques like fluoroscopic guidance and endoscopy, along with postoperative imaging to ensure proper catheter placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ommaya reservoirs for the treatment of leptomeningeal metastases. Sandberg, DI., Bilsky, MH., Souweidane, MM., et al.[2022]

The study involved 85 navigation-guided Ommaya reservoir placements in 77 patients with intracranial malignancies, demonstrating a very low complication rate of only 1.2%, with no cases of hemorrhage or infection.

Using the Medtronic STEALTH STATION TRIA navigation system allowed for real-time verification of catheter placement, resulting in appropriate positioning in all but one case, highlighting the safety and efficacy of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigation-guided Ommaya reservoir placement: implications for the treatment of leptomeningeal metastases. Takahashi, M., Yamada, R., Tabei, Y., et al.[2016]

In a study of 145 patients undergoing Ommaya reservoir placement, both fluoroscopic guidance and frameless stereotactic neuronavigation were found to be equally effective in terms of catheter placement accuracy and revision rates.

While fluoroscopy showed a slight advantage in proximity to the foramen of Monro, the overall complication rates were similar between the two methods, suggesting that surgeon preference and familiarity may be the deciding factors in choosing a technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image Guidance for Placement of Ommaya Reservoirs: Comparison of Fluoroscopy and Frameless Stereotactic Navigation in 145 Patients. Morgenstern, PF., Connors, S., Reiner, AS., et al.[2018]

Citations

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Pooled rates of outcome for IG compared with non-IG were 6.4% versus 14.1% for overall complications; 2.0% compared with 2.8% for catheter malfunction; 2.3% ...

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Complications from catheter placement during Ommaya reservoir insertion include hemorrhage, malfunction, infection and improper positioning. Rates of these ...

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pubmed.ncbi.nlm.nih.gov

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Ommaya reservoirs were present for 199,956 days and a median of 1,336 days per device. Median survival of the 52 patients still alive is 7.5 years. Only one ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5523660/

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Ommaya reservoir placement requires a high degree of precision to avoid chemotherapeutic toxicity to brain parenchyma. Ventricular catheter placement for an ...

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Safety of Ommaya reservoirs in children with brain tumors: a 20-year experience with 5472 intraventricular drug administrations in 98 patients. J Neuro ...