Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors
NCT ID: NCT06322602
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-02-28
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Ommaya reservoir placement
Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also optionally undergo lumbar puncture while on study. Patients also undergo CT or MRI on study.
Intracranial Catheter Placement
Undergo Ommaya reservoir placement
Lumbar Puncture
Undergo LP
Biopsy
Undergo biopsy
Biospecimen Collection
Undergo CSF sample collection
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Interventions
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Intracranial Catheter Placement
Undergo Ommaya reservoir placement
Lumbar Puncture
Undergo LP
Biopsy
Undergo biopsy
Biospecimen Collection
Undergo CSF sample collection
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned biopsy for suspected or previously diagnosed brain tumor as part of routine clinical care at Mayo Clinic (Rochester, Minnesota \[MN\])
* Willingness of the patient 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)
Exclusion Criteria
* Vulnerable populations including pregnant women, prisoners, and individuals \< 18 years old
* Patients who are not appropriate candidates for biopsy due to current or past medical history or uncontrolled current illness
* Prior history of any wound infection
* Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons may include, but will not be limited to, surgical anatomy, clinical evidence of immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Terry C. Burns, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-01762
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-009112
Identifier Type: -
Identifier Source: org_study_id
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