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Trial Title:
Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors
NCT ID:
NCT06322602
Condition:
Brain Neoplasms
Conditions: Official terms:
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Intracranial Catheter Placement
Description:
Undergo Ommaya reservoir placement
Arm group label:
Ommaya reservoir placement
Intervention type:
Procedure
Intervention name:
Lumbar Puncture
Description:
Undergo LP
Arm group label:
Ommaya reservoir placement
Other name:
LP
Other name:
spinal tap
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Ommaya reservoir placement
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo CSF sample collection
Arm group label:
Ommaya reservoir placement
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Cerebrospinal Fluid Collection
Other name:
CSF Collection
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Ommaya reservoir placement
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Summary:
This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to
collect biomarkers longitudinally in patients with brain tumor. A biomarker is a
measurable indicator of the severity or presence of the disease state. An Ommaya
reservoir is a small device that's implanted under the scalp. It allows the doctor to
take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The
identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive
approach for monitoring tumor growth and response to therapy. In the future, these
biomarkers may be used to help determine what treatments could be most effective and how
well a tumor has responded to prior therapy. Currently, limited long-term access to CSF
has made it difficult for studies to learn if collecting CSF at different points in the
treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow
for longitudinal biomarker collection in patients with brain tumor.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Clinical and radiographic evidence suggesting a diagnosis of a brain tumor
- Planned biopsy for suspected or previously diagnosed brain tumor as part of routine
clinical care at Mayo Clinic (Rochester, Minnesota [MN])
- Willingness of the patient 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)
- Adults lacking capacity to consent
Exclusion Criteria:
- Vulnerable populations including pregnant women, prisoners, and individuals < 18
years old
- Patients who are not appropriate candidates for biopsy due to current or past
medical history or uncontrolled current 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 include, but will not be limited to, surgical anatomy,
clinical evidence of immunosuppression, and/or elevated risk of wound infection due
to diabetes, smoking history, morbid obesity, or any other concerns
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Terry C. Burns, M.D., Ph.D.
Email:
Principal Investigator
Start date:
February 28, 2024
Completion date:
March 2029
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06322602
https://www.mayo.edu/research/clinical-trials
