20 Participants Needed

Ommaya Reservoir for Brain Cancer

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for monitoring brain tumors using a small device called an Ommaya reservoir, placed under the scalp during a biopsy. The reservoir enables doctors to collect cerebrospinal fluid (CSF) samples over time without repeated spinal taps. By analyzing these samples, researchers aim to identify biomarkers that indicate tumor status and treatment response. This trial may suit individuals with a suspected or diagnosed brain tumor who plan to undergo a biopsy at the Mayo Clinic and are willing to provide CSF samples in the future. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future brain tumor monitoring techniques.

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 collecting biomarkers in brain tumor patients?

Research has shown that placing an Ommaya reservoir is generally safe, though some risks exist. In a study of 501 placements, about 8% of patients developed infections related to the reservoir. These infections were serious, including conditions like meningitis (swelling around the brain and spinal cord) or cellulitis (a skin infection).

Other studies highlight the importance of precise reservoir placement to avoid complications. When done correctly, this procedure allows doctors to easily collect fluid around the brain and spine without repeated spinal taps.

Overall, while there is a small risk of infection, Ommaya reservoirs serve as a valuable tool for ongoing monitoring in patients with brain tumors.12345

Why are researchers excited about this trial?

Researchers are excited about the use of Ommaya reservoirs in brain tumor patients because this method allows for the direct collection of cerebrospinal fluid (CSF) over time. Unlike traditional biopsies that provide only a single snapshot of the tumor, the Ommaya reservoir enables continuous monitoring of biomarkers, offering a dynamic view of tumor changes and treatment responses. This could lead to more personalized treatment strategies, adapting therapies based on real-time data rather than relying solely on static, initial biopsy results.

What evidence suggests that the Ommaya reservoir is effective for collecting biomarkers in brain tumor patients?

Research has shown that the Ommaya reservoir is a useful tool for accessing cerebrospinal fluid (CSF) in the brain. This device allows doctors to collect CSF samples multiple times without performing a spinal tap. In this trial, participants will have an Ommaya reservoir placed during a standard of care biopsy. Studies have found that using the Ommaya reservoir, along with treatments like fluid removal and targeted radiation, helps control brain tumors in about 81.2% of cases. It is often used in brain cancer treatment to deliver medicine directly to the brain and to frequently check the CSF for monitoring conditions. This makes it a promising tool for tracking brain tumor growth and assessing treatment effectiveness over time.12678

Who Is on the Research Team?

TC

Terry C. Burns, M.D., Ph.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Inclusion Criteria

I agree to have my Ommaya reservoir sampled at least twice more.
I am unable to make my own medical decisions.
I am willing to sign the consent form for the trial.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ommaya Reservoir Placement

Patients undergo Ommaya reservoir placement during standard of care biopsy for longitudinal biomarker collection

1 day
1 visit (in-person)

Biomarker Collection

Longitudinal collection of cerebrospinal fluid (CSF) samples using the Ommaya reservoir

Up to 5 years
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness of biomarker collection

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Ommaya Reservoir Placement

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Ommaya reservoir placementExperimental Treatment6 Interventions

Find a Clinic Near You

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+

Citations

Ommaya Reservoir - StatPearls - NCBI Bookshelf

This device provides direct access to the cerebrospinal fluid (CSF), enabling repeated intraventricular drug administration—such as chemotherapy ...

Stereotactic aspiration alone or Ommaya placement and ...

Results. Overall rate of tumor control for combined treatment of Ommaya placement plus aspiration plus SRS was 81.2% (62.5–99.9%, p < 0.001) ...

Ommaya Reservoir Placement for Brain Tumor Biomarker ...

The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated operation ...

Ommaya Reservoir Placement for Brain Tumor Biomarker ...

The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated operation for ...

Image guidance for the placement of Ommaya reservoirs

The Ommaya reservoir is used widely in neuro-oncology, primarily for the instillation of intrathecal chemotherapy and frequent CSF sampling in patients with CNS ...

Ommaya reservoir-related infections: Clinical ...

Among 501 OR placements, 40 patients (8%) developed an ORRI. These presented with meningitis and/or meningoencephalitis (60%), cellulitis (20%), ...

Ommaya Reservoir: Care Instructions

An Ommaya (say "oh-MY-uh") reservoir is a small, soft, dome-shaped container. It is placed under your scalp. It has a thin tube called a catheter attached to it ...

Safe Placement of Ommaya Reservoirs in ...

The purpose of this study was to assess the risk of hemorrhagic complications in thrombocytopenic patients after Ommaya reservoir placement.