Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies

Study Purpose

This study explores whether DESI-MS can be used to identify cancerous vs.#46; noncancerous tissue during brain tumor surgery.

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.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Male and female patients age 18 and older.

- Patients or their legally authorized representative (LAR) able to provide written consent.

- Schedule to undergo tumor resection.

Exclusion Criteria:

- Pregnant women

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.	NCT06387979
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.
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.	Alfredo Quinones-Hinojosa, M.D.
Principal Investigator Affiliation	Mayo Clinic
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.	Glioma

Additional Details

PRIMARY OBJECTIVES:

I. To explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to: Ia.

Identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; Ib. Identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and therefore differentiate between IDH-mutant and wild-type gliomas. OUTLINE: This is an observational study. Patients undergo tissue sample collection and DESI-MS during standard of care surgery and have their medical records reviewed on study. Patients also undergo MRI per standard of care on study.

Arms & Interventions

Arms

: Observational

Patients undergo tissue sample collection and DESI-MS during standard of care surgery and have their medical records reviewed on study. Patients also undergo MRI per standard of care on study.

Interventions

Other: - Non-Interventional Study

Non-Interventional Study

Contact a Trial Team

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Mayo Clinic in Florida, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015