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Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age >= 18 years.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2.

- Diagnosis of the following, based on clinical and radiographic evidence: - A diffuse glioma, or a prior diagnosis of a diffuse glioma.

Diffuse gliomas include diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, oligodendroglioma and anaplastic oligodendroglioma.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04047264
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Terence C Burns, M.D., Ph.D.
Principal Investigator Affiliation	Mayo Clinic in Rochester
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Diffuse Astrocytoma, Diffuse Glioma, Glioblastoma, Metastatic Malignant Neoplasm in the Brain, Oligodendroglioma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Basic Science (microdialysis)

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

Interventions

Procedure: - Microdialysis

Undergo microdialysis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

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