Actively Recruiting
Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors
Led by Mayo Clinic · Updated on 2026-03-03
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of an Ommaya reservoir implanted during a biopsy to collect biomarkers over time in patients with brain tumors. Biomarkers are measurable signs that indicate the presence or severity of the disease. This approach aims to provide a minimally invasive way to monitor tumor growth and response to treatment by collecting cerebrospinal fluid (CSF) samples without repeated spinal taps, addressing the challenge of limited long-term CSF access in current studies. The study involves placing an Ommaya reservoir, a small device implanted under the scalp, during a standard biopsy procedure. Patients will have CSF extracted through this reservoir at multiple points during the study. Optionally, lumbar punctures may also be performed. Participants will undergo CT or MRI scans to monitor the tumor. The primary focus is to assess the feasibility and utility of this reservoir placement over a period of up to five years. Participants will be involved in regular procedures to collect CSF samples and undergo imaging tests such as CT or MRI. Researchers will monitor how well the reservoir placement works and how useful the collected biomarkers are for tracking the tumor. The study includes safety monitoring and aims to follow participants for up to five years to gather long-term data. The total duration of participation varies depending on individual treatment and follow-up schedules.
CONDITIONS
Brief Title
Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical and radiographic evidence suggesting a diagnosis of a brain tumor
- Planned biopsy for suspected or previously diagnosed brain tumor as part of routine clinical care at Mayo Clinic
- Willingness to provide informed consent
- Willingness to have the Ommaya reservoir sampled on at least two future occasions
- Willingness to have cerebrospinal fluid banked through the neuro-oncology biorepository (requires a separate signature)
You will not qualify if you...
- Adults lacking capacity to consent
- Vulnerable populations including pregnant women, prisoners, and individuals under 18 years old
- Patients not appropriate candidates for biopsy due to current or past medical history or uncontrolled illness
- Prior history of any wound infection
- Patients deemed by the surgeon as not optimal candidates for Ommaya reservoir placement due to surgical anatomy, immunosuppression, elevated risk of wound infection, diabetes, smoking history, morbid obesity, or other concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of biopsy and immediate recovery period
Participants undergo Ommaya reservoir placement at the time of their standard of care biopsy.
1 surgical visit (in-person)
Duration - Up to 5 years
Participants have cerebrospinal fluid collected through the Ommaya reservoir on at least two future occasions. Optional lumbar puncture and imaging with CT or MRI are also performed during this time to monitor biomarkers.
Multiple visits for CSF collection and imaging as scheduled
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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