Non-invasive Glioma Characterization Through Molecular Imaging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Patients unable to have MRI done
Trial design
Design model
Single group
Treatments tested in this trial
3T MRI Scanner
Device3T MRI Scanner providing Mega-laser sequence for single-voxel Magnetic Resonance Spectroscopy (MRS) data for 2 hydroxyglutarate (2HG) quantitation.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: IDH-Mutant Glioma PatientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2HG Concentration via 3T MRI Scanner
2HG concentrations as measured via 3T MRI Scanner.
Time frame
Day 12
2HG Concentration from tissue samples
2HG concentrations as measured via patient's surgically excised tissue sample ex vivo by tissue based liquid chromatography-mass spectrometry (LC-MS)
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov