Ommaya Reservoir Placement for Brain Tumor Biomarker Access

NCT04692337 | Recruiting DMC

• 3 other identifiers: 20-009226R33NS122096NCI-2021-02766
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (3)

• Collection of serial CSF samples for biobanking and biomarker discovery and validation - proportion of patients

  Assessed by the proportion of patients for whom longitudinal CSF can be collected.

  Through study completion, approximately 42 days

• Collection of serial CSF samples for biobanking and biomarker discovery and validation - number of times

  Assessed by the number of times longitudinal CSF collection occurred

  Through study completion, approximately 42 days

• Collection of serial CSF samples for biobanking and biomarker discovery and validation - volume obtained

  Assessed by the volumes obtained at each Ommaya tap.

  Through study completion, approximately 42 days

Secondary Outcomes (2)

• Incidence of Adverse Events of intra-operative Ommaya Reservoir placement

  Through study completion, approximately 42 days

• Scope of CSF biomarkers

  Through study completion, approximately 42 days

Study Arms (1)

Ommaya Reservoir placement

EXPERIMENTAL

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

Interventions

Intra-operative Ommaya Reservoir placement PROCEDURE

An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.

Ommaya Reservoir placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Willingness of the patient or an authorized representative 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Terry C. Burns, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Essa Sharif

CONTACT

507-538-6342; sharif.essa@mayo.edu

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: December 31, 2020
• Study Start: January 15, 2021
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Any time after publication.
• Access Criteria: Requests will be honored that could help advance the care of patients with brain tumors.

Locations

US (1)