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

Mayo Clinic

Status: Suspended

Conditions: Glioma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06387979

19-010725 (Other Identifier)

R33CA240181 (U.S. NIH Grant/Contract)

NCI-2024-01000 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 285 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

285 participants in 1 patient group

Observational

Description:

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.

Treatment:

Other: Non-Interventional Study