Ommaya Reservoir Placement for Brain Tumor Biomarker Access
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|ClinicalTrials.gov Identifier: NCT04692337|
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor||Procedure: Intra-operative Ommaya Reservoir placement||Not Applicable|
Most brain tumors remain incurable. Progress in clinical trials to identify better treatments has been slow. We hypothesize that longitudinal CSF access can provide insights regarding tumor identity, behavior and the efficacy of candidate therapies. Although multiple studies have evaluated CSF from patients with brain tumors, very few have collected CSF at multiple timepoints throughout the course of disease. However, multiple samples over time are needed to determine if candidate biomarkers accurately reflect the evolution of disease. CSF is typically obtained via lumbar puncture which is inconvenient and often uncomfortable. This protocol will evaluate the safety and feasibility of placing Ommaya reservoirs at the time of surgery. It is anticipated that reducing barriers to CSF access through placement of an Ommaya reservoir may expedite brain tumor research and facilitate the development of individualized treatment strategies.
An Ommaya Reservoir will be placed during a planned brain tumor operation. Following the routine portion of the planned procedure, the Ommaya reservoir will be placed under the scalp with the catheter tip placed either within the ventricle or the resection cavity. Presence of the Ommaya reservoir will enable CSF to be easily accessed at any time in the future. It is expected that CSF will be collected at 2 or more timepoints. CSF will be stored in the Mayo Clinic neuro-oncology biorepository and made available in a de-identified manner for multiple research projects. The patient and his/her provider(s) may take advantage of the Ommaya reservoir and/or banked CSF samples to facilitate participation in any relevant IRB-approved research study(s), and/or to facilitate individualized management. The details of each time the Ommaya is accessed will be documented as part of this trial.
|Study Type :||Interventional|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Ommaya Reservoir Placement for Brain Tumor Biomarker Access|
|Actual Study Start Date :||January 15, 2021|
|Estimated Primary Completion Date :||July 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Ommaya Reservoir placement
Subjects undergoing surgery for a confirmed or suspected brain tumor will have an Ommaya Reservoir placed at the time of surgery.
Procedure: Intra-operative Ommaya Reservoir placement
An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.
- Adverse Events of intra-operative Ommaya Reservoir placement [ Time Frame: through study completion, approximately 42 days ]Number of subjects to develop persistent adverse events deemed related (possibly, probably, definitely) to the insertion or use of Ommaya Reservoirs. Adverse events will be measured by CTCAE 5.0.
- Intra-operative Ommaya Reservoir placement [ Time Frame: through study completion, approximately 42 days ]Number of subjects whom Ommaya reservoir is successfully placed at the time of surgery without complication.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692337
|Contact: Bambi Wessel||(507) 293-1963||Wessel.Bambi@mayo.edu|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Bambi Wessel Wessel.Bambi@mayo.edu|
|Principal Investigator:||Terry C Burns, MD, PhD||Mayo Clinic|