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Trial record 2 of 11 for:    Recruiting Studies | Interventional Studies | brain cancer | United States | First posted from 10/09/2020 to 01/05/2021

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
Sponsor:
Information provided by (Responsible Party):
Terry Burns, Mayo Clinic

Brief Summary:
The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated operation for brain tumor. The Ommaya reservoir will facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of potential biomarkers for brain tumor research and individualized monitoring.

Condition or disease Intervention/treatment Phase
Brain Tumor Procedure: Intra-operative Ommaya Reservoir placement Not Applicable

Detailed Description:

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.

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Study Type : Interventional
Estimated Enrollment : 50 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years.
  • Clinical and radiographic evidence suggesting a diagnosis of a brain tumor.
  • Planned neurosurgical procedure resection of suspected or previously diagnosed brain tumor as part of routine clinical care.
  • Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN).
  • Ability to understand and the willingness to sign a written informed consent document.
  • 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)

Exclusion Criteria:

  • Vulnerable populations including pregnant women, prisoners and individuals <18 years old.
  • Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness.
  • Prior history of any wound infection
  • Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons could (but need not necessarily) include factors related to surgical anatomy, clinical evidence of significant immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns.

Information from the National Library of Medicine

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


Contacts
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Contact: Bambi Wessel (507) 293-1963 Wessel.Bambi@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Bambi Wessel       Wessel.Bambi@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Terry C Burns, MD, PhD Mayo Clinic
Additional Information:
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Responsible Party: Terry Burns, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04692337    
Other Study ID Numbers: 20-009226
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Protocol details and individualized de-identified patient data will be provided as supplemental files in the resulting publication. Any additional information not otherwise provided may be requested from the primary investigator.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Any time after publication.
Access Criteria: Requests will be honored that could help advance the care of patients with brain tumors.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases