Brain TumorNCT04692337
Ommaya Reservoir Placement for Brain Tumor Biomarker Access
A study testing Intra-operative Ommaya Reservoir placement in people with Brain Tumor, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Intra-operative Ommaya Reservoir placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Essa Sharif, 507-538-6342, sharif.essa@mayo.edu
Terry C. Burns, MD, PhD
About this study
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.
Read the detailed description
Most brain tumors remain incurable. Progress in clinical trials to identify better treatments has been slow. We hypothesize that longitudinal CSF access can provide insights regarding tumor identity, behavior and the efficacy of candidate therapies. Although multiple studies have evaluated CSF from patients with brain tumors, very few have collected CSF at multiple timepoints throughout the course of disease. However, multiple samples over time are needed to determine if candidate biomarkers accurately reflect the evolution of disease. CSF is typically obtained via lumbar puncture which is inconvenient and often uncomfortable. This protocol will evaluate the safety and feasibility of placing Ommaya reservoirs at the time of surgery. It is anticipated that reducing barriers to CSF access through placement of an Ommaya reservoir may expedite brain tumor research and facilitate the development of individualized treatment strategies.
An Ommaya Reservoir will be placed during a planned brain tumor operation. Following the routine portion of the planned procedure, the Ommaya reservoir will be placed under the scalp with the catheter tip placed either within the ventricle or the resection cavity. Presence of the Ommaya reservoir will enable CSF to be easily accessed at any time in the future. It is expected that CSF will be collected at 2 or more timepoints. CSF will be stored in the Mayo Clinic neuro-oncology biorepository and made available in a de-identified manner for multiple research projects. The patient and his/her provider(s) may take advantage of the Ommaya reservoir and/or banked CSF samples to facilitate participation in any relevant IRB-approved research study(s), and/or to facilitate individualized management. The details of each time the Ommaya is accessed will be documented as part of this trial.
- Conditions
- Brain Tumor
- Being tested
- Intra-operative Ommaya Reservoir placement
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative Ommaya Reservoir placementProcedure or surgery
An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.
| Study group | Role | What they receive |
|---|---|---|
| Ommaya Reservoir placement | Experimental | Subjects undergoing surgery for a confirmed or suspected brain tumor will have an Ommaya Reservoir placed at the time of surgery. Receives: Procedure: Intra-operative Ommaya Reservoir placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of serial CSF samples for biobanking and biomarker discovery and validation - proportion of patients
Assessed by the proportion of patients for whom longitudinal CSF can be collected.
Measured: Through study completion, approximately 42 days
Collection of serial CSF samples for biobanking and biomarker discovery and validation - number of times
Assessed by the number of times longitudinal CSF collection occurred
Measured: Through study completion, approximately 42 days
Collection of serial CSF samples for biobanking and biomarker discovery and validation - volume obtained
Assessed by the volumes obtained at each Ommaya tap.
Measured: Through study completion, approximately 42 days
Secondary outcomes (2)
Incidence of Adverse Events of intra-operative Ommaya Reservoir placement
Number of subjects to develop persistent adverse events deemed related (possibly, probably, definitely) to the insertion or use of Ommaya Reservoirs. Adverse events will be measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Through study completion, approximately 42 days
Scope of CSF biomarkers
Assessed by the number of assays run for each patient and the number of times the assays successfully detected an analyte under consideration as a candidate biomarker.
Measured: Through study completion, approximately 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start15 Jan 2021
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Terry C. Burns, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692337
- Sponsor's protocol ID
- 20-009226
- Other IDs
- R33NS122096, NCI-2021-02766, R01CA315861
- Status last verified
- Aug 2026
- First submitted
- 29 Dec 2020
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol details and individualized de-identified patient data will be provided as supplemental files in the resulting publication. Any additional information not otherwise provided may be requested from the primary investigator.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ommaya Reservoir Placement for Brain Tumor Biomarker Access
- ClinicalTrials.gov ID
- NCT04692337
- Acronym / sponsor ID
- 20-009226
- Conditions
- Brain Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Cancer Institute (NCI)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Most brain tumors remain incurable. Progress in clinical trials to identify better treatments has been slow. We hypothesize that longitudinal CSF access can provide insights regarding tumor identity, behavior and the efficacy of candidate therapies. Although multiple studies have evaluated CSF from patients with brain tumors, very few have collected CSF at multiple timepoints throughout the course of disease. However, multiple samples over time are needed to determine if candidate biomarkers accurately reflect the evolution of disease. CSF is typically obtained via lumbar puncture which is inconvenient and often uncomfortable. This protocol will evaluate the safety and feasibility of placing Ommaya reservoirs at the time of surgery. It is anticipated that reducing barriers to CSF access through placement of an Ommaya reservoir may expedite brain tumor research and facilitate the development of individualized treatment strategies.
An Ommaya Reservoir will be placed during a planned brain tumor operation. Following the routine portion of the planned procedure, the Ommaya reservoir will be placed under the scalp with the catheter tip placed either within the ventricle or the resection cavity. Presence of the Ommaya reservoir will enable CSF to be easily accessed at any time in the future. It is expected that CSF will be collected at 2 or more timepoints. CSF will be stored in the Mayo Clinic neuro-oncology biorepository and made available in a de-identified manner for multiple research projects. The patient and his/her provider(s) may take advantage of the Ommaya reservoir and/or banked CSF samples to facilitate participation in any relevant IRB-approved research study(s), and/or to facilitate individualized management. The details of each time the Ommaya is accessed will be documented as part of this trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ommaya Reservoir placement | Experimental | Procedure: Intra-operative Ommaya Reservoir placementSubjects undergoing surgery for a confirmed or suspected brain tumor will have an Ommaya Reservoir placed at the time of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-operative Ommaya Reservoir placementAn Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid. | Procedure or surgery | Ommaya Reservoir placement |
Primary outcome
Collection of serial CSF samples for biobanking and biomarker discovery and validation - proportion of patients
Time frame: Through study completion, approximately 42 days
Assessed by the proportion of patients for whom longitudinal CSF can be collected.
Collection of serial CSF samples for biobanking and biomarker discovery and validation - number of times
Time frame: Through study completion, approximately 42 days
Assessed by the number of times longitudinal CSF collection occurred
Collection of serial CSF samples for biobanking and biomarker discovery and validation - volume obtained
Time frame: Through study completion, approximately 42 days
Assessed by the volumes obtained at each Ommaya tap.
2 secondary outcomes
Incidence of Adverse Events of intra-operative Ommaya Reservoir placement
Time frame: Through study completion, approximately 42 days
Scope of CSF biomarkers
Time frame: Through study completion, approximately 42 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Protocol details and individualized de-identified patient data will be provided as supplemental files in the resulting publication. Any additional information not otherwise provided may be requested from the primary investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terry C. Burns, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-operative Ommaya Reservoir placement in people with Brain Tumor, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Essa Sharif (507-538-6342, sharif.essa@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of serial CSF samples for biobanking and biomarker discovery and validation - proportion of patients (time frame: Through study completion, approximately 42 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.