Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387979
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01000 | REGISTRY | None | None |
| 19-010725 | OTHER | None | None |
| P30CA015083 | NIH | None | None |
| R33CA240181 | NIH | Mayo Clinic in Florida | httpsreporternihgovquickSearchR33CA240181 |