Clinical trial NCT04047264: Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
Official title: Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma
Glioblastoma
Metastatic Malignant Neoplasm in the Brain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2019-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intraoperative microdialysis during neurosurgery for central nervous system malignancies. A biomarker is a measurable indicator of the severity or presence of disease state. Information collected in this study may help doctors to develop new strategies to better diagnose, monitor, and treat brain tumors.

Detailed description: PRIMARY OBJECTIVE:

I. Determine biomarkers of in situ gliomas across a diverse patient cohort using intra-operative microdialysis to sample extracellular metabolites.

SECONDARY OBJECTIVE:

I. Evaluate the yield and specificity of microdialysate D-2HG as a candidate tumor biomarker to differentiate between IDH-mutated and IDH-wildtype gliomas.

II. Identify biomarkers of tumor-associated processes including brain edema, brain infiltration with non-enhancing tumor, and tumor-associated hypoxia or necrosis.

III. Determine the contribution of blood-brain barrier disruption to metabolite abundance within enhancing gliomas.

IV. Determine the feasibility of detecting stable-isotope labeled metabolites in human microdialysate.

EXPLORATORY/CORRELATIVE OBJECTIVES:

I. Perform untargeted metabolomics of tumor microdialysate to elucidate extracellular biomarkers reflective of human central nervous system malignancy subtype, grade, and tumor region.

II. Banking of microdialysate specimens for future analyses.

OUTLINE:

Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection.

After completion of study, patients are followed up for 42 days.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Diagnosis of the following, based on clinical and radiographic evidence:

  * Any glioma
  * Metastatic brain tumor of any primary origin
  * Epileptic focus requiring surgical resection
* Planned neurosurgical procedure for purposes of biopsy or resection of suspected or previously diagnosed brain tumor (primary or metastatic) or epileptic focus as part of routine clinical care
* Willing to undergo neurosurgical resection or biopsy at Mayo Clinic (Rochester, Minnesota \[MN\])
* Ability to understand and the willingness to sign a written informed consent document

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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 42 days
measure: Targeted metabolomics
timeFrame: Up to 42 days
Secondary outcomes:
measure: Microdialysate D-2HG
timeFrame: Up to 42 days
measure: Non-enhancing (FLAIR)- region metabolites
timeFrame: Up to 42 days
measure: Necrotic core metabolites
timeFrame: Up to 42 days
measure: Percentage of samples in which stable isotope labeled L-methionine- 13C5, 15N detected
timeFrame: Up to 42 days
Other outcomes:
measure: Microdialysate oncometabolites
timeFrame: Up to 42 days
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Terence C Burns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: