GliomaNCT06387979
Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies
An observational study of Glioma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Non-Interventional Study
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 15 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suspected to have glioma tumors scheduled to undergo tumor resection.
Who may be able to join
- 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
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Glioma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start26 Oct 2020
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alfredo Quinones-Hinojosa, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387979
- Sponsor's protocol ID
- 19-010725
- Other IDs
- NCI-2024-01000, 19-010725, R33CA240181
- Status last verified
- Dec 2025
- First submitted
- 24 Apr 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies
- ClinicalTrials.gov ID
- NCT06387979
- Acronym / sponsor ID
- 19-010725
- Conditions
- Glioma
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Funding issues
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected to have glioma tumors scheduled to undergo tumor resection.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | Observational |
Primary outcome
Pathological state of the tissue
Time frame: Up to 5 years
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.
Percentage of tumor infiltration
Time frame: Up to 5 years
Will 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 mutations
Time frame: Up to 5 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Quinones-Hinojosa, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological state of the tissue (time frame: Up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.