Ommaya Reservoir Placement for Brain Cancer

Overseen By Clinical Trials Referral Office

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

50 Participants Needed

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. ^{1 2 3 4 5}

How 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. ^{1 3 4 6 7}

Research Team

Terry C. Burns, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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 Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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 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 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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ommaya reservoirs for the treatment of leptomeningeal metastases. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Optimal use of the Ommaya reservoir in clinical oncology. [2005]

3. Germany pubmed.ncbi.nlm.nih.gov

Navigation-guided Ommaya reservoir placement: implications for the treatment of leptomeningeal metastases. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Nursing management of patients with an implanted Ommaya reservoir. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Experience with Ommaya reservoir in 120 consecutive patients with meningeal malignancy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Ommaya Reservoir Insertion: A Technical Note. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Image Guidance for Placement of Ommaya Reservoirs: Comparison of Fluoroscopy and Frameless Stereotactic Navigation in 145 Patients. [2018]