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Ommaya reservoir placement for Brain Tumor

N/A
Recruiting
Led By Terry C. Burns, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of Ommaya reservoir placement
Secondary outcome measures
Utility of Ommaya reservoir

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ommaya reservoir placementExperimental Treatment5 Interventions
Patients undergo Ommaya reservoir placement during standard of care biopsy. Patients then undergo extraction of CSF while on study. Patients may also undergo lumbar puncture while on study. Patients also undergo CT on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Lumbar Puncture
2016
Completed Phase 3
~510

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,478 Total Patients Enrolled
Terry C. Burns, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester

Frequently Asked Questions

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~7 spots leftby Mar 2029