Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Time Frame
Start Date: 2024-02-28
Estimated Completion Date: 2029-03
Participants
Target number of participants: 20
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov

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