What this study is
This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor.
What's being tested
- Intracranial Catheter Placement
Intervention · PROCEDURE
Undergo Ommaya reservoir placement
- Lumbar Puncture
Intervention · PROCEDURE
Undergo LP
- Biopsy
Intervention · PROCEDURE
Undergo biopsy
- Biospecimen Collection
Intervention · PROCEDURE
Undergo CSF sample collection
- Computed Tomography
Intervention · PROCEDURE
Undergo CT
- Magnetic Resonance Imaging
Intervention · PROCEDURE
Undergo MRI
Study details
- Official title
- Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection
- Sponsor
- Mayo Clinic
- Conditions
- Brain Neoplasms
- Enrolling
- 30 people
- Starts
- 2024-02-28
- Est. completion
- 2029-03-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 (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)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic in Rochester
Rochester, Minnesota, United States
- Clinical Trials Referral Office · Contact855-776-0015mayocliniccancerstudies@mayo.edu
- Terry C. Burns, M.D., Ph.D. · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 23-009112
Principal investigator
Terry C. Burns, M.D., Ph.D.
Mayo Clinic in Rochester
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.