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Trial record 3 of 12 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | brain cancer | United States | Start date from 01/06/2021 to 04/08/2021

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

Tracking Information
First Submitted Date  ICMJE December 29, 2020
First Posted Date  ICMJE December 31, 2020
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE January 15, 2021
Estimated Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ommaya Reservoir Placement for Brain Tumor Biomarker Access
Official Title  ICMJE Ommaya Reservoir Placement for Brain Tumor Biomarker Access
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Brain Tumor
Intervention  ICMJE Procedure: Intra-operative Ommaya Reservoir placement
An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.
Study Arms  ICMJE 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.
Intervention: Procedure: Intra-operative Ommaya Reservoir placement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 29, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bambi Wessel (507) 293-1963 Wessel.Bambi@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04692337
Other Study ID Numbers  ICMJE 20-009226
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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.
Responsible Party Terry Burns, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Terry C Burns, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP