Ommaya Placement for Biomarker Collection

Overview

About this study

The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated tumor surgery in order to facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of exploratory and future tumor biomarkers for individualized monitoring.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 cerebrospinal fluid (CSF) banked through the neuro-oncology biorepository (requires a separate signature).

 Exclusion Criteria:

  • Vulnerable populations: pregnant women, prisoners, or the mentally handicapped.
  • 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 may (but need not necessarily) include 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. 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Terence Burns, M.D., Ph.D.

Open for enrollment

Contact information:

Amanda Munoz Casabella M.D.

MunozCasabella.Amanda@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions