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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06387979
• Other study ID #: 19-010725
• Secondary ID: NCI-2024-0100019
• Status: Recruiting
• Start date: October 26, 2020
• Est. completion date: October 15, 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioma

Intervention

Other:
• Non-Interventional Study
Non-Interventional Study

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological state of the tissue	Will 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.	Up to 5 years
Primary	Percentage of tumor infiltration	Will estimate the percentage of tumor infiltration in tissue biopsies by monitoring depletion of NAA and aberrations of the phospholipid signature of neurological tissue.	Up to 5 years
Primary	Presence of IDH mutations	Will 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.	Up to 5 years