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Non-invasive Glioma Characterization Through Molecular Imaging

Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03684109
Enrollment
30
Registered
2018-09-25
Start date
2019-01-25
Completion date
2027-01-31
Last updated
2026-04-20

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

Conditions

Brain Tumor, Glioma, Malignant Glioma, Malignant Primary Brain Tumor, Primary Brain Tumor

Keywords

Non-invasive glioma characterization, Molecular Imaging, Isocitrate Dehydrogenase (IDH) Mutations, MRI-Based Sequencing

Brief summary

MRI-based sequences can provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Detailed description

This is a pilot study aiming at developing and optimizing MRI-based sequences to provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Interventions

3T MRI Scanner providing Mega-laser sequence for single-voxel Magnetic Resonance Spectroscopy (MRS) data for 2 hydroxyglutarate (2HG) quantitation.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

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

Inclusion criteria

* Adults (≥18 year old) * Subjects with suspected or confirmed gliomas and who will have a medically indicated biopsy or resection of his/her brain lesion.

Exclusion criteria

* Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Patients unable to have MRI done

Design outcomes

Primary

MeasureTime frameDescription
2HG Concentration via 3T MRI ScannerDay 12HG concentrations as measured via 3T MRI Scanner.
2HG Concentration from tissue samplesDay 12HG concentrations as measured via patient's surgically excised tissue sample ex vivo by tissue based liquid chromatography-mass spectrometry (LC-MS)

Countries

United States

Contacts

CONTACTNathalie Padron
npadron@med.miami.edu305-243-3530
PRINCIPAL_INVESTIGATORMacarena De La Fuente, MD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026