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

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

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06387979
Enrollment
285
Registered
2024-04-29
Start date
2020-10-26
Completion date
2026-10-15
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

Brief summary

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

Detailed 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.

Interventions

OTHERNon-Interventional Study

Non-Interventional Study

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pathological state of the tissueUp to 5 yearsWill use desorption electrospray ionization mass spectrometry (DESI-MS) to identify cancerous versus noncancerous tissue monitoring depletion of N-acetyl aspartate (NAA) and aberrations of the phospholipid signature (components of the cell membrane) of neurological tissue.
Percentage of tumor infiltrationUp to 5 yearsWill estimate the percentage of tumor infiltration in tissue biopsies by monitoring depletion of NAA and aberrations of the phospholipid signature of neurological tissue.
Presence of IDH mutationsUp to 5 yearsWill use DESI-MS to identify the presence of isocitrate dehydrogenase (IDH) mutations by monitoring the 2-hydroxyglutarate (2HG) and therefore differentiate between IDH-mutant and wild-type gliomas.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026