Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors

Brain Neoplasms Clinical Trial

Official title:

Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322602
• Other study ID #: 23-009112
• Secondary ID: NCI-2024-01762
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: March 2029

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2029
• Est. primary completion date: March 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Procedure:
• Intracranial Catheter Placement
Undergo Ommaya reservoir placement
• Lumbar Puncture
Undergo LP
• Biopsy
Undergo biopsy
• Biospecimen Collection
Undergo CSF sample collection
• Computed Tomography
Undergo CT

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Ommaya reservoir placement	Will be assessed based on the percent of patients for whom an Ommaya reservoir is successfully placed at the time of tissue biopsy without attributable complication.	Up to 5 years
Secondary	Utility of Ommaya reservoir	Will be assessed based on the percent of patients for whom multiple (2 or more) cerebrospinal fluid (CSF) samples are successfully obtained as a result of their participation in this protocol.	Up to 5 years