Clinical trial NCT06322602: Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors
Official title: Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Neoplasms
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)
* Adults lacking capacity to consent

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

Primary outcomes:
measure: Feasibility of Ommaya reservoir placement
timeFrame: Up to 5 years
Secondary outcomes:
measure: Utility of Ommaya reservoir
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Terry C. Burns, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: